Page 1 of 3GE HealthcareURGENT MEDICAL DEVICE CORRECTION 3000 N. Grandview Blvd. - W440Waukesha, WI 53188, USA GEHC Ref# 32047To: Nurse Managers, Labor & Delivery/NICUBio-Medical Engineering Department ManagersRisk Management DirectorsRE: Infant Warmer System (IWS) Hot “Heater Head” Screw could Fall onto the BedGE Healthcare has recently become aware of a potential safety issue related to loose screws in the “Heater Head” of certainInfant Warmer System (IWS) devices. Please ensure that all potential users, as well as those servicing these units, in yourfacility are made aware of this safety notification and the recommended actions.SafetyIssueHot screws from the “Heater Head” of the IWS could fall onto the bed if the “Heater Head” assembly hasbeen improperly serviced. This situation can be clinically hazardous because thermal injury to a patientcould result. Two injuries have been reported as a result of this issue.SafetyInstructionsThe potential for this issue to occur is only present if the “Heater Head” assembly has been improperlyserviced.As a result, if “Heater Head” service has been performed in the past, check to ensure that the screws aretightened 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 partof 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.AffectedProductDetailsRefer 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, 3300IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.Affected Products Not Affected ProductsRendered PDF File Page 2 of 4 DOC1881503, Rev:1Released
