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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER STATURE SIT TO STAND LIFT

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APEX HEALTHCARE MFG INC HOYER STATURE SIT TO STAND LIFT Back to Search Results
Model Number HOY-STATURE
Device Problems Inadequate or Insufficient Training; Device Handling Problem
Event Date 02/09/2015
Event Type  Injury  
Event Description

It was reported to the manufacturer by the facility (b)(6), per the facility 2 cna's were transferring a resident with the hoyer stature when it tipped over. The resident landed on one of the cna's and caused cna head to hit bedside table and floor. The other cna sustained injuries to her leg when she also fell. Both cna's were sent to the urgent care clinic. The cna's have hematoma on head and leg as well as swelling to the head, shoulder and leg. A joerns representative visited the facility on (b)(6) 2015. The lift and sling were evaluated. The casters on the lift were "sticking", making it more difficult to move the lift. The facility ordered new casters for all their lifts. During the incident, training provided by joerns rep. It was admitted that the cna put her foot on the leg of the lift and pulled the resident back into the chair by pulling on the sling. This caused the lift to tip over onto the cna's. It was also mentioned that the staff had tipped the lift in the past, but it did not go all the way over and was not reported to management until this incident when the lift went all the way over. Complaint # (b)(4) was entered into our system.

 
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Brand NameHOYER STATURE
Type of DeviceSIT TO STAND 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 Key4577973
Report Number3009402404-2015-00005
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type User facility
Reporter Occupation
Type of Report Initial
Report Date 02/24/2015,02/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2015
Is This An Adverse Event Report? Yes
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? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2015
Distributor Facility Aware Date02/09/2015
Device Age1 yr
Event Location Nursing Home
Date Report TO Manufacturer02/24/2015
Date Manufacturer Received02/09/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2014
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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