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<Date of Letter Deployment>
To: Nurse Managers, Labor & Delivery/NICU
Bio-Medical Engineering Department Managers
Risk Management Directors
RE: Infant Warmer System (IWS) Hot "Heater Head" Screw could Fall onto the Bed
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the "Heater Head" of certain
Infant Warmer System (IWS) devices. Please ensure that all potential users, as well as those servicing these units, in your
facility are made aware of this safety notification and the recommended actions.
Safety
Hot screws from the "Heater Head" of the IWS could fall onto the bed if the "Heater Head" assembly has
Issue
been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient
could result. Two injuries have been reported as a result of this
Safety
The potential for this issue to occur is only present if the "Heater Head" assembly has been improperly
Instructions
serviced.
As a result, if "Heater Head" service has been performed in the past, check to ensure that the screws are
tightened as soon as the unit becomes available.
If the "Heater Head" assembly has not been serviced, check to ensure that the screws are tightened as part
of your next regularly scheduled annual Preventive Maintenance check.
The attached Service Manual Addendum provides instructions for checking and tightening the screws.
During each annual Preventive Maintenance check, continue to ensure that the screws are tight.
Affected
Refer to Product Images below for images of Affected and Not affected products.
Product
Details
Affected model numbers: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300
IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.
Rendered PDF File Page 2 of 4
URGENT MEDICAL DEVICE CORRECTION
Affected Products
GE Healthcare
3000 N. Grandview Blvd. - W440
Waukesha, WI 53188, USA
GEHC Ref# 32047
issue.
Not Affected Products
Page 1 of 3
DOC1881503, Rev:1
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Related Manuals for GE 2001 IWS
Summary of Contents for GE 2001 IWS
- Page 1 RE: Infant Warmer System (IWS) Hot “Heater Head” Screw could Fall onto the Bed GE Healthcare has recently become aware of a potential safety issue related to loose screws in the “Heater Head” of certain Infant Warmer System (IWS) devices. Please ensure that all potential users, as well as those servicing these units, in your facility are made aware of this safety notification and the recommended actions.
- Page 2 “Customer Response” form. Contact If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at Information 1-800-437-1171 or your local Service Representative.
- Page 3 Rendered PDF File Page 4 of 4 DOC1881503, Rev:1 GE Healthcare MEDICAL DEVICE CORRECTION CONFIRMATION GE REF: 32047 CUSTOMER RESPONSE REQUIRED We request that you PLEASE COMPLETE and return this form to GE Healthcare within two (2) weeks. Customer/Consignee Name: _____________________________________________________________ Street Address: _____________________________________________________________ City/State/ZIP/Country: _____________________________________________________________...
- Page 4 Addendum Infant Warmer System Heater Reflector Screws Maintenance Check For future reference, add this addendum to your Infant Warmer System Service Manual. 2098189-001 A © 2016 General Electric Company...
- Page 5 Language Disclaimer WARNING: This service document is available in English only. (EN) • If a customer’s service provider requires a language other than English, it is the customer’s responsibility to provide translation services. • Do not attempt to service the equipment unless this service manual has been consulted and is understood.
- Page 6 UPOZORENJE Ovaj servisni priručnik dostupan je na engleskom jeziku. (HR) • Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod. • Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj servisni priručnik. Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili pacijenta •...
- Page 7 Versuchen Sie nicht diese Anlage zu warten, ohne diese Serviceanleitung gelesen und verstanden zu haben. • Wird diese Warnung nicht beachtet , so kann es zu Verletzungen des Kundendiensttechnikers, des Bedieners oder des Patienten durch Stromschläge, mechanische oder sonstige Gefahren kommen. ΠΡΟΕΙΔΟΠΟΙΗΣΗ Το παρόν εγχειρίδιο σέρβις διατίθεται μόνο στα αγγλικά.
- Page 8 FIGYELMEZTETÉS Ezen karbantartási kézikönyv kizárólag angol nyelven érhető el. (HU) • Ha a vevő szolgáltatója angoltól eltérő nyelvre tart igényt , akkor a vevő felelőssége a fordítás elkészíttetése. • Ne próbálja elkezdeni használni a berendezést , amíg a karbantartási kézikönyvben leírtakat nem értelmezték.
- Page 9 BRĪDINĀJUMS Šī apkopes rokasgrāmata ir pieejama tikai angļu valodā. (LV) • Ja klienta apkopes sniedzējam nepieciešama informācija citā valodā, klienta pienākums ir nodrošināt tulkojumu. • Neveiciet aprīkojuma apkopi bez apkopes rokasgrāmatas izlasīšanas un saprašanas. Šī brīdinājuma neievērošanas rezultātā var rasties elektriskās strāvas trieciena, mehānisku •...
- Page 10 ATENÇÃO Este manual de assistência técnica só se encontra disponível em inglês. (PT-PT) • Se qualquer outro serviço de assistência técnica solicitar este manual noutro idioma, é da responsabilidade do cliente fornecer os serviços de tradução. • Não tente reparar o equipamento sem ter consultado e compreendido este manual de assistência técnica.
- Page 11 ATENCION Este manual de servicio sólo existe en inglés. (ES) • Si el encargado de mantenimiento de un cliente necesita un idioma que no sea el inglés, el cliente deberá encargarse de la traducción del manual. • No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este manual de servicio.
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Page 12: Maintenance Schedule
Maintenance Schedule Perform this maintenance procedure annually to make sure the two heater reflector screws (front and back) are tight. This schedule recommends the minimum frequencies. Always follow hospital and local regulations. Failure to perform this maintenance per recommended frequency can result WARNING: in patient harm or injury Required Tools... - Page 13 For units that have serial numbers starting with the prefix HCC (see Figure 2): a. Use a Phillips screw driver to remove the screw and lock washer from the top of the cushioned heater head. b. Use a Phillips screw driver to remove the screw and alarm light lens from the bottom of the heater head.
- Page 14 Locate the two reflector screw nuts (front and back) on the top of the heater housing assembly. (See Figure 4 and Figure 5). Figure 4: Locating the Front Reflector Screw Nut Figure 5: Locating the Back Reflector Screw Nut Pass the tip of a long Phillips screw driver through the heater grille at an angle to engage the front reflector screw, and then use a wrench or nut driver to loosen the nut about one turn (Figure 6).
- Page 15 Reverse step 3 or step 2 to re-install the heater head plate and cover. NOTE: If the heater reflector screw or nut is lost, you can order the reflector screw by GE part number 0140-6124-114 and the nut by GE part number 6600-0382-400.
- Page 16 IWS Service Manual Addendum 2098189-001 Rev A...
- Page 17 上海GE中国科技园 Tel + 1 954 744 5600 地址：中国上海市浦东张江高科技园华佗路1号, 201203 Tel + (8621) 38777888 Fax + (8621) 38777402 Brazil Only GE Healthcare Clinical Systems Equipamentos Médicos Ltda Australia 1300 722 229 Av. Paulista, 37 - 13º andar China 800 810 8188 CEP: 01311-902 - Cerqueira César...