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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE USA P-SERIES; PATIENT LIFT
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HANDICARE USA P-SERIES; PATIENT LIFT Back to Search Results
Model Number P-440
Device Problems Circuit Failure (1089); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2020
Event Type  malfunction  
Event Description
After charging the p440 for 4 hours with a new charger the customer took it off the charger and decided to use it.The customer stated, when they unplugged the charger the p440 motor immediately burst into flames.The customer said they immediately put out the fire with a fire extinguisher.No one was hurt.
 
Manufacturer Narrative
The unit was investigated with pictures provided by the customer.A heat event is evident by the photos.The pcb is flame retardant, the case is flame retardant, and the heat event self-extinguished.This issue is caused by an intermittent connection of a fuse mount on the pcb.The mount and fuse were improved to a more secure hold.The new fuse sits more flush to the mount, reducing the possibility of it being hit or damaged during pcb handling or mounting.
 
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Brand Name
P-SERIES
Type of Device
PATIENT LIFT
Manufacturer (Section D)
HANDICARE USA
10888 metro court
maryland heights, mo
MDR Report Key9734642
MDR Text Key206127762
Report Number3007802293-2020-00004
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
Remedial Action Replace
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP-440
Device Catalogue Number303070
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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