FDA Adverse Event Injury Summary report: N

3M BAIR HUGGER WARMING UNIT

MDR report key: 2885090 · Received December 12, 2012

Report

Report Number: 2110898-2012-00065
Event Type: Injury
Date Received: December 12, 2012
Date of Event: November 11, 2012
Report Date: November 14, 2012
Manufacturer: 3M HEALTH CARE
Product Code: DWJ
PMA / PMN Number: 960167
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

3M WILL NEED TO EVALUATE THE UNIT TO CONFIRM IF BIOMED RESULTS ARE ACCURATE. THIS IS A VERY OLD UNIT. THEY STATED THE UNIT WAS ON THE HIGHEST TEMPERATURE WHEN BEING USED. THE WARMING BLANKET USED WITH THE WARMING UNIT WAS: 3M BAIR HUGGER FULL BODY BLANKET, MODEL 300, ORDER NUMBER 30000, NO LOT NUMBER WAS PROVIDED. PMA/510(K): APPLICABLE TO BOTH WARMING UNIT AND BLANKET. THE MODEL 500R HAS AN INDEPENDENT OVER-TEMPERATURE ALARM. THERE IS AN OVER-TEMPERATURE INDICATOR ON THE USER INTERFACE AND IF THERE IS AN OVER-TEMPERATURE CONDITION, THE INDICATOR ILLUMINATES AND AN AUDIBLE ALARM SOUNDS AND THE HEATER SHUTS OFF.

Description of Event or Problem · 1

CUSTOMER REPORTED A HYPOTHERMIC, VERY CRITICAL, (B)(6) MALE PT WITH MULTIPLE ISSUES, SUSTAINED 2ND TO 3RD DEGREE BURNS WITH BLISTERS TO 8-10% OF HIS LEFT LATERAL LEG FROM THE KNEE TO ANKLE FOLLOWING 3.5 HOURS OF WARMING WITH A 500/OPERATING ROOM WARMING UNIT. REPORTEDLY, PT WAS SENT TO WOUND CARE WITH THE NO INFO ABOUT TREATMENT. A PT BLANKET WAS PLACED OVER THE WARMING BLANKET (MODEL 300) AND A SHEET WAS PLACED BETWEEN THE PT AND THE WARMING BLANKET AS IS THEIR PRACTICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	3M BAIR HUGGER WARMING UNIT	SYSTEM, THERMAL REGULATING 870.5900 DWJ	DWJ	3M HEALTH CARE	500OR	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Other	NONE SPECIFIED