MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Lot Number 042121

Device Problems Defective Component (2292); Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Philips infant heel warmers, lot# 042121 exp 10/02/23 full box was defective.Did not activate or become warm as they are designed to do.

• Brand Name: PHILIPS INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS
• MDR Report Key: 12532336
• MDR Text Key: 273746202
• Report Number: MW5104189
• Device Sequence Number: 1
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2021

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?: No
• Device Operator: No Information
• Device Lot Number: 042121
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1