MAUDE MDR 6410575

MDR report key
6410575
Report number
MW5068495
Event key
0
Event type
3
Date of event
2017-02-28
Date received
2017-03-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POSEY PADSPOSEY ELITE BED PADS (BED ALARM)POSEY PRODUCTSFNJ6251T007I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-100

Event Narratives#

D

Patient 1

BURNING SMELL NOTED UPON ENTERING ROOM. DISCOVERED SHEET ON BED ALARM TO BE CHARRED WITH A YELLOW COLOR. THE BED ALARM PAD WAS HOT TO THE TOUCH WITH A YELLOW CHARRING AREA, AND SMELLED LIKE MECHANICAL BURNING. A NURSE WALKED INTO HER PATIENT'S ROOM AND NOTICED A "BURNING" MECHANICAL SMELL. SHE INVESTIGATED AND DISCOVERED THAT THE POSEYT ELITE BED PAD THAT THE PATIENT HAD BEEN LAYING ON FOR LESS THAN 24 HOURS HAD "SPARKED" AND BURNED THE BLANKET UNDER THE PATIENT. THE BED ALARM PAD WAS "HOT" TO THE TOUCH AND HAD A YELLOW CHARRING AREA IN THE CENTER OF THE PAD (APPROXIMATELY 5 X 4 IN SIZE). THERE WAS NO HARM TO THE PATIENT. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: PREVENT PATIENT FROM FALLING.