MAUDE Adverse Event Report: PHILIPS PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER

Catalog Number 1223

Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

Used a philips infant heel warmer prior to heel stick.When we removed it to do the pku, it had exploded and the inside contents were all over the baby's foot.It did not burn the foot.Second time in the past 2 days this has happened.

• Brand Name: PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER
• Type of Device: PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 4664978
• MDR Text Key: 5608345
• Report Number: MW5041915
• 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: 03/23/2015

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?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 1223
• Device Lot Number: NONE
• Other Device ID Number: 1223
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2015
• Patient Sequence Number: 1
• Patient Age: 2 DA