MAUDE Adverse Event Report: STRYKER MEDICAL INTOUCH; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 2131

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: INTOUCH
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002 522
• MDR Report Key: 3731154
• MDR Text Key: 19020309
• Report Number: 3731154
• Device Sequence Number: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 2131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2014
• Patient Sequence Number: 1