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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

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PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR Back to Search Results
Model Number SR358L
Device Problem Fire (1245)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been made available for evaluation as of yet.Should the device or further information become available, a follow-up report will then be issued.
 
Event Description
Provider alleges consumer alleges the hand control caught on fire.
 
Event Description
Provider alleges consumer alleges the hand control caught on fire.
 
Manufacturer Narrative
The root cause of the failure appears to be a damaged harness; the pcb and all controls of the hand-control had not failed.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Type of Device
ELECTRIC POSITIONING CHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
Manufacturer (Section G)
N/A
n/a
n/a
n/a
Manufacturer Contact
kelly livingston
401 york ave
duryea, PA 18642
8008008586
MDR Report Key12512665
MDR Text Key272690567
Report Number2530130-2021-00099
Device Sequence Number1
Product Code INO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070950
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSR358L
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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