FDA Adverse Event Malfunction Summary report: N

INFA-THERM TRANSPORT MATTRESS

MDR report key: 11337240 · Received February 17, 2021

Report

Report Number
11337240
Event Type
Malfunction
Date Received
February 17, 2021
Date of Event
January 26, 2021
Report Date
February 1, 2021
Manufacturer
PHILLIPS NORTH AMERICA LLC.
Product Code
IMD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

IN EVENING, NEONATAL NURSE PRACTITIONER (NNP) UNCOVERED INFANT TO ACCESS UMBILICAL LINES AND NOTICED THAT THERE WAS NO BLANKET BETWEEN INFANT AND CHEMICAL WARMER. THE INFANT WAS NOT UNDER LIGHTS AND WAS ON THE WARMER FOR A TOTAL OF 3.5 HOURS. DAYSHIFT RN LIFTED BABY, NNP HELD ETT, AND RN ADDED BLANKET UNDER INFANT. THE DURATION OF CONTACT (WITHOUT BLANKET IN BETWEEN) WAS ABOUT 20 MINUTES. RN, DAYSHIFT RN, NNP, AND RESIDENT ASSESSED INFANT. NO REDNESS WAS SEEN AT THIS TIME. ABOUT ONE HOUR LATER, NEONATAL NURSE PRACTITIONER (NNP) WAS REMOVING STERILE FIELD AND BOTH SHE AND RN NOTICED REDNESS AND BLISTERING PRESENT ACROSS BUTTOCKS AND RIGHT LEG. NNP AND RESIDENT CONTACTED DERMATOLOGY, AS WOUND WAS NOT AVAILABLE. THE PATIENT HAD 10% OF TOTAL BODY SURFACE AREA PARTIAL THICKNESS THERMAL CONTACT BURNS. THE INFANT WAS CLEANED WITH WARM, SPAY WATER AND THEN XEROFORM WAS APPLIED COATED WITH BACITRACIN TWICE A DAY TO BURN WOUNDS, AND CHANGED, AS NEEDED. CHEMICAL MATTRESS SUSPECTED TO HAVE CONTRIBUTED TO SIGNIFICANT BURN THAT PATIENT SUFFERED. ON REVIEW, THIS INFANT TRANSPORT MATTRESS HAS A STATED MAXIMUM TEMPERATURE OF 117¿F WHICH IS SIGNIFICANTLY HIGHER THAN MANY OTHER MATTRESSES ON THE MARKET (104-105¿F) ASSOCIATION OF WOMEN'S HEALTH, OBSTETRIC AND NEONATAL NURSES (AWHONN) GUIDELINES FOR NEONATAL BATH WATER SAY NO HIGHER THAN 104¿F WHICH WOULD BE THE CLOSEST GUIDELINE TO THIS PRODUCT. SPECIFIC MATTRESS USED IN THIS INJURY IS UNAVAILABLE AS IT WAS DISCARDED. LOT NUMBERS HAVE BEEN PULLED FROM CURRENT STOCK ON THE SHELF AND REMOVED FROM PATIENT USE. THIS IS ALL THE INFORMATION AVAILABLE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
233261 INFA-THERM TRANSPORT MATTRESS PACK, HOT OR COLD, DISPOSABLE IMD PHILLIPS NORTH AMERICA LLC. 989805616831 061820, 100520, 061920

Patients

Seq Age Sex Outcome Treatment
1