MAUDE Adverse Event Report: GE HEALTHCARE OHMEDA; PANDA WARMER

Device Problem Mechanical Problem (1384)

Patient Problem Burn(s) (1757)

Event Date 05/05/2016

Event Type  malfunction  

Event Description

While infant was under infant warmer, a screw from the top housing by the warming element fell down on the baby.This resulted in burns to the infant's beck and shoulder.

• Brand Name: OHMEDA
• Type of Device: PANDA WARMER
• Manufacturer (Section D): GE HEALTHCARE; 9900 innovation dr.; wauwatosa WI 53226
• MDR Report Key: 5669314
• MDR Text Key: 45809467
• Report Number: MW5062382
• Device Sequence Number: 1
• Product Code: FMT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Weight: 3