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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESENCE LIFT PATIENT ELECTRIC LIFT

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APEX HEALTHCARE MFG INC HOYER PRESENCE LIFT PATIENT ELECTRIC LIFT Back to Search Results
Model Number HOY-PRESENCE
Device Problems Inadequate or Insufficient Training; Device Handling Problem
Event Date 05/26/2014
Event Type  Injury  
Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility the resident was being moved from the wheelchair to the bed. After the staff pick the resident up in the lift, they moved the wheelchair out of the way. The staff heard a pop from the sling. The left side upper hook of the sling came off the cradle. The resident fell out of the sling and landed on the floor. She was transported to the er for x-ray. She has a fractured left shoulder and the arm/shoulder are not immobilized. The sling that was being used during the lift was invacare sling. Complaint# (b)(4) was entered into our system.

 
Manufacturer Narrative

Joerns sending the report to the manufacturer.

 
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Brand NameHOYER PRESENCE LIFT
Type of DevicePATIENT ELECTRIC LIFT
Manufacturer (Section D)
APEX HEALTHCARE MFG INC
min hsiung
chi yi
TW 
Manufacturer Contact
felicia banks
2100 design road
arlington , TX 76014
8008260270
MDR Report Key3900974
Report Number3009402404-2014-00015
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 06/16/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHOY-PRESENCE
Device Catalogue NumberHOY-PRESENCE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/16/2014
Distributor Facility Aware Date05/26/2014
Event Location Nursing Home
Date Report TO Manufacturer06/16/2014
Date Manufacturer Received06/11/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 06/16/2014 Patient Sequence Number: 1
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