MAUDE Adverse Event Report: LINET LLC MULTICARE SIDERAIL PADS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 09/10/2017

Event Type  malfunction  

Event Description

A staff member in the intensive cardiac care unit (iccu) stated that she hurt her back attempting to put the bed side rail down with the manufacturer's seizure pad in place.These are the new pads that are in place on every bed due to staff request.Manufacturer response for seizure pads, linet multicare siderail pads (per site reporter).The rep came out to hospital to review issue with the bed/siderail "seizure pads" with iccu manager in charge.He demonstrated the ease of use (without a patient present in bed & in a made bed) and he showed the proper way to use the pads and the rails.No other issues have been reported to the manufacturer regarding this issue per rep.

• Brand Name: MULTICARE SIDERAIL PADS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LINET LLC; steve krueger; 13455 bobby lane; elm grove WI 53122
• MDR Report Key: 7013591
• MDR Text Key: 91462328
• Report Number: 7013591
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: MCKIT-NAMSP
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.; THE BED WAS BEING USED AND THE SEIZURE PADS ARE A R