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GE Healthcare
URGENT MEDICAL DEVICE CORRECTION
3000 N. Grandview Blvd. - W440
Waukesha, WI 53188, USA
<Date of Letter Deployment>
GEHC Ref# 32047
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
Issue
Hot screws from the “Heater Head” of the IWS could fall onto the bed if the “Heater Head” assembly has
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 issue
.
Safety
Instructions
The potential for this issue to occur is only present if the “Heater Head” assembly has been improperly
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
Product
Details
Refer to Product Images below for images of Affected and Not affected products.
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.
Affected Products
Not Affected Products
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DOC1881503, Rev:1
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