MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INFANT TRANSPORT MATTRESS

Model Number 1015

Device Problem Excessive Heating (4030)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/26/2021

Event Type  Injury  

Event Description

It was reported to philips that a patient suffered redness and blistering present across the buttocks and right leg due to the chemical mattress.The device was being used on a patient at the time of the event,.

• Brand Name: INFANT TRANSPORT MATTRESS
• Type of Device: INFANT TRANSPORT MATTRESS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11571421
• MDR Text Key: 242319706
• Report Number: 1218950-2021-10198
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K936084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1015
• Device Catalogue Number: 1015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2021
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization