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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE USA C-SERIES; PATIENT LIFTS, PRODUCT CODE: FSA
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HANDICARE USA C-SERIES; PATIENT LIFTS, PRODUCT CODE: FSA Back to Search Results
Model Number C-625
Device Problems Material Frayed (1262); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2019
Event Type  malfunction  
Event Description
Annual maintenance was being done on a c-625 lift.The technician noted the strap on the ceiling lift was frayed in two places because battery acid came into contact with the ceiling lift.
 
Manufacturer Narrative
Our investigation concluded that the customer's contention that battery acid damaged the lifting strap is unsubstantiated, and that the strap fraying occurred due to a different, unknown cause.The customer declined to return the c-625 lift to handicare for further investigation, making any further attempt at investigation speculative.Both the batteries and the lift strap were replaced on lift serial number (b)(6) as a correction.Since the root cause of the issue was not identified, no additional action is possible.
 
Event Description
Annual maintenance was being done on a c-625 lift.The technician noted the strap on the ceiling lift was frayed in two places because battery acid came into contact with the ceiling lift.
 
Manufacturer Narrative
Our investigation concluded that the customer's contention that battery acid damaged the lifting strap is unsubstantiated, and that the strap fraying occurred due to a different, unknown cause.The customer declined to return the c-625 lift to handicare for further investigation, making any further attempt at investigation speculative.Both the batteries and the lift strap were replaced on lift serial number (b)(6) as a correction.Since the root cause of the issue was not identified, no additional action is possible.
 
Event Description
Annual maintenance was being done on a c-625 lift.The technician noted the strap on the ceiling lift was frayed in two places because battery acid came into contact with the ceiling lift.
 
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Brand Name
C-SERIES
Type of Device
PATIENT LIFTS, PRODUCT CODE: FSA
Manufacturer (Section D)
HANDICARE USA
10888 metro court
maryland heights MO 63043 2413
MDR Report Key9536029
MDR Text Key198569682
Report Number3007802293-2019-00047
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 foreign,other
Type of Report Initial,Followup,Followup
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberC-625
Was Device Available for Evaluation? No
Date Manufacturer Received12/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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