MAUDE Adverse Event Report: GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC OMNIBED GIRAFFE; WARMER, INFANT RADIANT

Model Number 6650-0077-901

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

"while performing routine care with patient with isolette hood raised, noticed a coppery/burning smell in the room, patient's mother also noted the smell.The patient's mother reported seeing smoke by the lamp of the isolette, i did not see the smoke but shut off the lamp then shut off the isolette and swapped out the isolette for a new one.A red tag was placed on the malfunctioning isolette." -nurse.Approximately a week ago, a "burning smell" was reported on an infant warmer to clinical engineering.A thermal scanner was used to find the defective solid state relay.Ge was called.Ge tech support said, "there were no known issues with the solid state relay".A new component was ordered and replaced and device returned to service.Side note: this was the second unit that failed in a year with the same problem.The serial numbers were similar.A separate medsun report was created for that one with the identification and problem details in it.A "burning smell" was reported on an infant warmer to clinical engineering, and patient removed and device removed from service for repair.The report was confirmed and a thermal imaging device was used to find the defection component.Ordered and received a new component and installed.The device was fully tested and returned to service.

Event Description

"while performing routine care with patient with isolette hood raised, noticed a coppery/burning smell in the room, patient's mother also noted the smell.The patient's mother reported seeing smoke by the lamp of the isolette, i did not see the smoke but shut off the lamp then shut off the isolette and swapped out the isolette for a new one.A red tag was placed on the malfunctioning isolette." -nurse.Approximately a week ago, a "burning smell" was reported on an infant warmer to clinical engineering.A thermal scanner was used to find the defective solid state relay.Ge was called.Ge tech support said, "there were no known issues with the solid state relay".A new component was ordered and replaced and device returned to service.Side note: this was the second unit that failed in a year with the same problem.(see below) the serial numbers were similar.A separate medsun report was created for that one with the identification and problem details in it.A "burning smell" was reported on an infant warmer to clinical engineering, and patient removed and device removed from service for repair.The report was confirmed and a thermal imaging device was used to find the defection component.Ordered and received a new component and installed.The device was fully tested and returned to service.

• Brand Name: OMNIBED GIRAFFE
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC; 9900 innovation drive; wauwatosa WI 53226
• MDR Report Key: 7901400
• MDR Text Key: 121453670
• Report Number: 7901400
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6650-0077-901
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 DA