MAUDE Adverse Event Report: GE HEALTHCARE GIRAFFE INFANT WARMER; WARMER, INFANT RADIANT

Model Number M1118179-024011

Device Problems Break (1069); Kinked (1339); Noise, Audible (3273)

Patient Problem No Code Available (3191)

Event Date 04/01/2018

Event Type  malfunction  

Event Description

We had a warmer break when a baby was in the warmer.The nurse was alerted from the other room when a loud noise occurred.She responded to the room to find the patient hanging off the bed with the side rail broken down.She quickly transferred the baby to another warmer.Infant had kicked the end of the warmer.The latch was apparently broken but the warmer not taken out of service.The end sides were taped to the other sides, but the infant had some tubes that were taped in between, so it wasn't clear that the tape was to keep the warmer together or left over from the other items.The nurse heard the sound of the warmer end flopping down and looked over and saw the saturation probe light hanging off the bed.She went into the room immediately and the infant was at the end of the bed with his foot hanging over.Biomed replaced bedside assembly and confirmed the unit locks.Infant incubator returned to service.

• Brand Name: GIRAFFE INFANT WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 7482926
• MDR Text Key: 107247945
• Report Number: 7482926
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: M1118179-024011
• Other Device ID Number: 670152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1