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

Model Number 1015

Device Problem Excessive Heating (4030)

Patient Problem Insufficient Information (4580)

Event Date 08/07/2022

Event Type  Death  

Event Description

The customer reported the infant was placed on philips infatherm mattress.Several hours after use, large burn/abrasion noted on infants back.Infant suffered fluid loss/injury as result of the burn.The device was in clinical use at the time of the event.The infant deceased.

Manufacturer Narrative

Medwatch # (b)(4).Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the infant was placed on philips infatherm mattress.Several hours after use, large burn/abrasion noted on infants back.Infant suffered fluid loss/injury as result of the burn.The device was in clinical use at the time of the event.The infant deceased.The burn resulted in fluid loss and injury to the patient skin.Though it was noted the infant had a poor prognosis and multiple medical complications prior to the event, the reported burn and the injuries sustained due to the burn, likely contributed to the subsequent death.The customer was unable to provide specific details of the device usage at the time of the event and the device was not returned for evaluation.Additionally, the customer did not respond to requests for additional information and therefore we are unable to confirm the final disposition of the device.

Manufacturer Narrative

The customer reported that a premature infant (aged 22 weeks, 6 days), delivered via caesarian section, was placed on philips infatherm mattress.Several hours after device use, large burn/abrasion were noted on the infants back.The infant suffered fluid loss/injury as result of the burn.Infant death was reported.The customer states that the facility received the philips infatherm mattress from vendor dci - distribution cooperative, inc on 14-jun-2022.He philips infatherm mattress was under recall as a result of a labeling related issue.The customer was unable to provide specific details of the device usage at the time of the event.The device was not returned by the customer for evaluation.A clinical harm review was performed by a philips clinical expert and determined the following: the premature infant (aged 22 weeks, 6 days) developed a burn/abrasion on their back after being placed on the device for warming.The burn resulted in fluid loss and injury to their skin.Though it was noted the infant had a poor prognosis and multiple medical complications prior to the event, the reported burn and the injuries sustained due to the burn, likely contributed to the subsequent death.We are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information.The customer did confirm that philips infant transport mattresses are no longer being used by the medical facility.The investigation concludes that no further action is required at this time.

• 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: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15893375
• MDR Text Key: 304596508
• Report Number: 1218950-2022-00984
• 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 Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1015
• Device Catalogue Number: 1015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 5 MO