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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: POSEY PRODUCTS POSEY PADS POSEY ELITE BED PADS (BED ALARM)

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POSEY PRODUCTS POSEY PADS POSEY ELITE BED PADS (BED ALARM) Back to Search Results
Lot Number 6251T007
Device Problems Charred (1086); Sparking (2595)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/28/2017
Event Type  malfunction  
Event Description
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.
 
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Brand NamePOSEY PADS
Type of DevicePOSEY ELITE BED PADS (BED ALARM)
Manufacturer (Section D)
POSEY PRODUCTS
5635 peck road
arcadia CA 91006 0020
MDR Report Key6410575
MDR Text Key70185892
Report NumberMW5068495
Device Sequence Number1
Product Code FNJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number6251T007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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