MAUDE Adverse Event Report: GE MEDICAL SYSTEMS GE PANDA WARMER; PANDA WARMER, RADIANT

Model Number PANDA IRES

Device Problem Crack (1135)

Patient Problem Fall (1848)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Plastic hinge at foot of panda warmer cracked and resulted in a failure of the end plastic panels.The end panel opened due to the cracked plastic and infant fell to floor.

• Brand Name: GE PANDA WARMER
• Type of Device: PANDA WARMER, RADIANT
• Manufacturer (Section D): GE MEDICAL SYSTEMS
• MDR Report Key: 8194184
• MDR Text Key: 131416405
• Report Number: 8194184
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PANDA IRES
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 1 DA