Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN DRIVE; HALF BED RAIL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DRIVE
Type of Device
HALF 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 Other
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
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age85 YR
Patient Weight57
-
-