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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE DRIVE MEDICAL; FULL BODY SLING
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DRIVE DEVILBISS HEALTHCARE DRIVE MEDICAL; FULL BODY SLING Back to Search Results
Model Number 13222L
Device Problem Break (1069)
Patient Problem Fall (1848)
Event Date 12/26/2017
Event Type  Injury  
Event Description
On (b)(6) 2017 at approximately 11:55 am two cnas were transferring a resident from their bed to her electric wheelchair via a bariatric mechanical lift when two of the nylon straps on the lift sling broke from the sling and the resident rolled sideways to the floor approximately 4 feet from the ground.The straps on the lift separated from the sling perfectly straight across the ribbing along the stitching that connects the straps to the sling.The sling appeared to have no other cosmetic defects.The resident was in a bariatric lift sling that was appropriate for their weight.The cnas reported that prior to placing the lift under the resident, they did not see any issues with the lift pad.
 
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Brand Name
DRIVE MEDICAL
Type of Device
FULL BODY SLING
Manufacturer (Section D)
DRIVE DEVILBISS HEALTHCARE
port washington NY 11050
MDR Report Key7168597
MDR Text Key96694165
Report NumberMW5074418
Device Sequence Number1
Product Code FNG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/03/2018
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 Other
Device Model Number13222L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/04/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age69 YR
Patient Weight129
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