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 09/25/2017

Event Type  malfunction  

Event Description

Approximately one year ago, a "burning smell" was reported on an infant warmer to clinical engineering.The patient was removed and the device was removed from service for repair.The report was confirmed and a thermal imaging device was used to find the defective component.Ordered and received a new component and installed.The device was fully tested and returned to service.Side note: approximately 1 month ago, again a "burning smell" was reported on a similar infant warmer to clinical engineering.This was not the same infant warmer but a close sn.A separate incident report and report was created for that one with the identification and problem details in it.

• 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: 7901427
• MDR Text Key: 121453052
• Report Number: 7901427
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1