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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOERNS HEALTHCARE HOYER LIFT, VERTICLE POWER PATIENT LIFT

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JOERNS HEALTHCARE HOYER LIFT, VERTICLE POWER PATIENT LIFT Back to Search Results
Model Number HOY-STATURE
Device Problems Off-Label Use; Inadequate or Insufficient Training
Event Date 12/17/2013
Event Type  No Answer Provided  
Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility one of the sling clips came off the lift, dropping the patient. The patient has no injuries. The sling that was used to lift the patient is manufactured by arjo huntleigh. The director of business development-patient handling for joerns visited the facility on (b)(4) 2014 to inspect the lift and sling. In his report he stated that "the arjo huntleigh sling does not fit the cradle properly. The sling can be placed on the cradle at the pins however the sling clip does not securely clip into place on the cradle. " complaint (b)(4) has been entered into our system.

 
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Brand NameHOYER LIFT, VERTICLE
Type of DevicePOWER PATIENT LIFT
Manufacturer (Section D)
JOERNS HEALTHCARE
stevens point WI
Manufacturer (Section G)
ARJO HUNTLEIGH (FORMERLY BHM MEDICAL)
2001 tanguay magog qc
J1X 5Y5
CA  J1X 5Y5
Manufacturer Contact
felicia banks
2100 design rd
arlington , TX 76014
8008260270
MDR Report Key3603930
Report Number3009402404-2014-00001
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/21/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHOY-STATURE
Device Catalogue NumberHOY-STATURE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/21/2014
Distributor Facility Aware Date12/17/2013
Device Age4 yr
Event Location Nursing Home
Date Report TO Manufacturer01/21/2014
Date Manufacturer Received01/07/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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