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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE HALF BED RAIL
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UNKNOWN DRIVE HALF BED RAIL Back to Search Results
Model Number 15021BV
Device Problem Component Missing (2306)
Patient Problems Death (1802); Physical Entrapment (2327)
Event Date 08/06/2016
Event Type  Death  
Event Description
(b)(4) is the initial importer of the device which is a half bed rail. This bed rail was paired initially paired with an invacare mattress. The end-user was coded to hospice care. A new third party service provider for hospice care delivered a drive air mattress model 14027 to replace the invacare mattress. The delivery was supposed to include a peri cover that did not arrive with the mattress. No other changes were made to the setup. Per summons, despite noticing a new mattress, the staff did not perform a new bed rail safety assessment. It was reported that patient was immobile and incontinent. The next morning the patient was found entrapped between the mattress and the rail.
 
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Brand NameDRIVE
Type of DeviceHALF BED RAIL
Manufacturer (Section D)
UNKNOWN
MDR Report Key7447936
MDR Text Key106087238
Report Number2438477-2018-00016
Device Sequence Number1
Product Code FNJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018,04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nursing Assistant
Device Model Number15021BV
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2018
Distributor Facility Aware Date08/09/2017
Event Location Other
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
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