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

Model Number M1112198

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2020

Event Type  malfunction  

Event Description

Baby warmer knob came off of control panel.

• Brand Name: PANDA
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): GE HEALTHCARE, LLC; 3000 n. grandview blvd.; waukesha WI 53188
• MDR Report Key: 10778174
• MDR Text Key: 214344723
• Report Number: 10778174
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1112198
• 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: 09/30/2020
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1