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

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.

• Brand Name: POSEY PADS
• Type of Device: POSEY ELITE BED PADS (BED ALARM)
• Manufacturer (Section D): POSEY PRODUCTS; 5635 peck road; arcadia CA 91006 0020
• MDR Report Key: 6410575
• MDR Text Key: 70185892
• Report Number: MW5068495
• Device Sequence Number: 1
• Product Code: FNJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 6251T007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR