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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE STAIRLIFTS B.V HANDICARE; FREECURVE
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HANDICARE STAIRLIFTS B.V HANDICARE; FREECURVE Back to Search Results
Model Number FREECURVE
Device Problem Unintended Movement (3026)
Patient Problem Fall (1848)
Event Date 05/13/2020
Event Type  malfunction  
Manufacturer Narrative
The unit has been returned to the manufacturer and the investigation is ongoing.
 
Event Description
The unit passed through the first end stop, the chair tilted, and then the unit stopped.The user fell from the chair but was uninjured.
 
Manufacturer Narrative
The unit was returned for investigation; it ran > 3000 runs without problems.The datacard was not returned, so further investigation into the root cause is not possible.A new unit was provided to the customer which is running without problems on the original rail.
 
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Brand Name
HANDICARE
Type of Device
FREECURVE
Manufacturer (Section D)
HANDICARE STAIRLIFTS B.V
newtonstraat 35
p.o. box 39
heerhugowaard, noord-holland 1700 AA
NL  1700 AA
MDR Report Key10123568
MDR Text Key194937653
Report Number3013423626-2020-00010
Device Sequence Number1
Product Code PCD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFREECURVE
Device Catalogue NumberC0020057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Distributor Facility Aware Date05/25/2020
Device Age10 MO
Event Location Home
Initial Date Manufacturer Received 05/13/2020
Initial Date FDA Received06/05/2020
Supplement Dates Manufacturer Received05/13/2020
Supplement Dates FDA Received10/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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