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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESENCE; PATIENT LIFT
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APEX HEALTHCARE MFG INC HOYER PRESENCE; PATIENT LIFT Back to Search Results
Model Number HOY-PRESENCEWSC
Device Problem Inadequate or Insufficient Training (1643)
Patient Problem Fall (1848)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to the manufacturer by the end user, per the end user, the resident was in the sling.The facility staff member pushed the button on the lift to raise the resident in the sling and started to pull the lift/sling away from the bed.The sling came unhooked on the right shoulder and the resident slid out of the sling and landed on the floor although his legs were still on the bed.The resident was transported to the local er for evaluation and did not sustain any injuries.(b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift has not been returned.
 
Manufacturer Narrative
D4.The lift model was incorrect on the the original medwatch report submitted.
 
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Brand Name
HOYER PRESENCE
Type of Device
PATIENT LIFT
Manufacturer (Section D)
APEX HEALTHCARE MFG INC
no.6, industrial 2nd road
tou chiao industrial park
min hsiung shiang, chai yi hsien
CH 
MDR Report Key9555434
MDR Text Key198745313
Report Number3009402404-2020-00002
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberHOY-PRESENCEWSC
Device Catalogue NumberHOY-PRESENCEWSC
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age83 YR
Patient Weight86
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