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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE B/LIFT HANDSET 5 RETRO US BATHLIFT HAND CONTROL

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HANDICARE B/LIFT HANDSET 5 RETRO US BATHLIFT HAND CONTROL Back to Search Results
Model Number 311
Device Problem Unknown (for use when the device problem is not known)
Event Date 03/14/2014
Event Type  Malfunction  
Event Description

The bathlift was used by the customer in the tub. The bathlift operated correctly lowering into the tub by depressing the down button on the hand control. When required to rise up out of the tub through operation of the up button on the hand control, the bathlift would not operate. The customer reported that no injuries had occurred during the incident. To date, handicare have not received the device back from the customer for evaluation.

 
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Brand NameB/LIFT HANDSET 5 RETRO US
Type of DeviceBATHLIFT HAND CONTROL
Manufacturer (Section D)
HANDICARE
82 first ave.
the pensnett estate
kingswinford, west midlands DY6 7FJ
UK  DY6 7FJ
Manufacturer (Section G)
RISE LIFTS, INC.
344 north reading rd.
ephrata PA 17522
Manufacturer Contact
344 north reading rd.
ephrata , PA 17522
MDR Report Key3736728
Report Number3005536958-2014-00003
Device Sequence Number1
Product CodeFNG
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/01/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/01/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number311
Device Catalogue NumberBP-300-500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2014
Distributor Facility Aware Date03/18/2014
Device Age6 mo
Event Location Home
Date Report TO Manufacturer04/01/2014
Is this a Reprocessed and Reused Single-Use Device? No

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