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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESSURE LIFT ELECTRIC PT LIFT

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APEX HEALTHCARE MFG INC HOYER PRESSURE LIFT ELECTRIC PT LIFT Back to Search Results
Model Number HOY-PRESSURE
Device Problems Inadequate or Insufficient Training; Device Handling Problem
Event Date 04/04/2015
Event Type  Injury  
Event Description

It was reported to the mfr by the end user, per the end user the resident was being transferred from the bed to a chair using the lift. The lift was going in sideways, legs closed and brakes unlocked. One cna was operating the lift and the other cna was pulling the sling to properly position the resident in the chair. The lift tipped sideways in the opposite direction of the cna pulling the sling. The resident hit the wall hard and slid down the wall to land on the floor. The sling was unhooked from the lift and a nurse was called for assistance and to assess the pt. The resident was sent to the hosp for eval. She sustained a broken patella and was put into a leg brace. The resident has returned to the facility. The lift was inspected by facility maintenance and returned to service after the incident. The hoyer sling involved was returned to service as well. Proper lift and sling usage training was given by a joerns healthcare rep a few weeks prior to this incident. (b)(4).

 
Manufacturer Narrative

Joerns sending the report to the manufacturer.

 
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Brand NameHOYER PRESSURE LIFT
Type of DeviceELECTRIC PT LIFT
Manufacturer (Section D)
APEX HEALTHCARE MFG INC
min hsiung, chi yi
TW 
Manufacturer Contact
felicia banks
2100 design rd
arlington , TX 76014
8008260270
MDR Report Key4734280
Report Number3009402404-2015-00011
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 04/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHOY-PRESSURE
Device Catalogue NumberHOY-PRESSURE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2015
Distributor Facility Aware Date04/04/2015
Device Age5 yr
Date Report TO Manufacturer04/21/2015
Date Manufacturer Received04/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2010
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: 04/22/2015 Patient Sequence Number: 1
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