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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC. HOYER PRESENCE LIFT PT LIFTER

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APEX HEALTHCARE MFG INC. HOYER PRESENCE LIFT PT LIFTER Back to Search Results
Model Number HOY-PRESENCE
Device Problems Inadequate or Insufficient Training; Device Handling Problem
Event Date 10/07/2014
Event Type  No Answer Provided  
Event Description

It was reported to the mfr by the facility ((b)(6)), per the facility, the resident was being transferred from a wheelchair to a shower chair. The resident was placed in the sling and the sling attached to the lift by two nurses' aides. The nurses' aides were moving the lift by using the lift handle and the bottom of the sling that the resident was seated in. The cradle tilted back and allowed the sling loop to slide off the hook. The resident fell out of the sling. The resident was transported to the hosp for eval/testing and returned to the facility the same with no injuries. The sling that was being used during the transport was manufactured by invacare. (b)(4) were entered into our sys to retrieve the lift and sling for investigation at joerns. As of this writing, the lift and sling have not been returned to joerns.

 
Manufacturer Narrative

Joerns sending the report to the mfr.

 
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Brand NameHOYER PRESENCE LIFT
Type of DevicePT LIFTER
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 Key4374519
Report Number3009402404-2014-00020
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 10/15/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/16/2014
Is This An Adverse Event Report? Yes
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 FDA10/15/2014
Distributor Facility Aware Date10/07/2014
Device Age3 yr
Event Location Nursing Home
Date Report TO Manufacturer10/15/2014
Date Manufacturer Received10/08/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2011
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: 10/16/2014 Patient Sequence Number: 1
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