MAUDE Adverse Event Report: ENERSYS GENESIS NP1812BFR 12 V 17.2AH; BED, AC-POWERED ADJUSTABLE HOSPITAL, BATTERY

Lot Number 080520DN

Device Problems Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Staff came into patient's room while the patient was out for a procedure.The staff noticed an unusual odor coming from the bed and went to investigate.Upon physical investigation it was found that the bed below the mattress was warm to touch.The bed was removed from the room.Upon further inspection, it was found that the two 12 volt batteries on the bed were hot to the touch, bulging, and leaking.Staff checked other beds at the facility, and 3-4 other beds by the same manufacturer with the same battery were found with the same condition.

• Brand Name: GENESIS NP1812BFR 12 V 17.2AH
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL, BATTERY
• Manufacturer (Section D): ENERSYS; 2366 bernville road; reading PA 19605
• MDR Report Key: 3731154
• MDR Text Key: 19020309
• Report Number: 3731154
• Device Sequence Number: 2
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/21/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 080520DN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2014
• Patient Sequence Number: 1