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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCARE MEDCARE STAND AND WEIGH

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MEDCARE MEDCARE STAND AND WEIGH Back to Search Results
Model Number 400007
Device Problem Device Tipped Over
Event Date 07/02/2015
Event Type  Malfunction  
Manufacturer Narrative

The lift was inspected by the facility maintenance supervisor and found to be operating correctly. The last preventative maintenance performed on the device was in march 2015 and this is a first time occurrence for this type of incident. The lift is not being returned for evaluation. We reenacted how this could occur in several ways with similar results as what occurred in the facility following improper foot placement by not having both feet entirely on the loft. Therefore, we believe the patient was not standing with booth heels on the platform fully and caused the lift to tilt to one side.

 
Event Description

Lift tilted while in use with a patient. Facility reported the individual stepped on the edge of the platform causing it to tilt to one side. The facility indicated no injuries occurred to report.

 
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Brand NameMEDCARE STAND AND WEIGH
Type of DeviceMEDCARE STAND AND WEIGH
Manufacturer (Section D)
MEDCARE
burnsville MN 55337
Manufacturer Contact
steve kilburn
10888 metro ct
maryland heights , MO 63043
3142198614
MDR Report Key5011600
Report Number3007802293-2015-00032
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 08/11/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number400007
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2011
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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