MAUDE Adverse Event Report: PHILIPS NORTH AMERICA, LLC. PHILIPS INFATHERM; INFANT TRANSPORT MATTRESS

Device Problems Overheating of Device (1437); Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 08/07/2022

Event Type  Death  

Event Description

A 22 6/7 week infant delivered via c-section for nrfht and preeclampsia.Infant required chemical mattress warming multiple times after birth.Placed on philips infatherm mattress, several hours after use large burn/abrasion noted to infant's back.Infant prognosis poor prior to this event, but infant suffered fluid loss/injury as a result of burn.Infant died (withdrawal of support) less than 24 hours after birth with multiple medical complications.After event, healthcare facility learned that this particular mattress is under active recall for temperature related reasons.This shipment of mattresses was received from supplier in june of this year.Of note, this facility was made aware of the recall in january of 2022, but at that time there were no philips infatherm mattresses in the facility.We are investigating how/why we ordered/received a recalled medical device at this time.

• Brand Name: PHILIPS INFATHERM
• Type of Device: INFANT TRANSPORT MATTRESS
• Manufacturer (Section D): PHILIPS NORTH AMERICA, LLC.
• MDR Report Key: 15690433
• MDR Text Key: 302583504
• Report Number: 15690433
• Device Sequence Number: 1
• Product Code: IMD
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American