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

Model Number GIRAFFE

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

Infant in giraffe omnibed.Phototherapy initiated by utilizing on board phototherapy light.Outlet and plug started smoking.Nurse immediately unplugged and disconnected isolette from power.Infant transferred to new bed and giraffe sent to biomed for repair and engineering services contacted for repair of wall outlet.

• Brand Name: GIRAFFE OMICARE
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): GE HEALTHCARE; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 12141971
• MDR Text Key: 260687892
• Report Number: 12141971
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIRAFFE
• 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: 07/07/2021
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 DA