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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 LC525IM
Medical Device Problem Code Fire (1245)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The customer discarded the hand control.The remainder of the device has not yet been made available for evaluation.Should further information or the device become available, a follow-up report will then be issued.
 
Event or Problem Description
Alleges being reclined back in the chair when she smelled something burning and alleges the hand control caught on fire.Alleges she yanked the control from the chair and threw it outside and roommate threw the hand control away.
 
Additional Manufacturer Narrative
Only the lift chair frame and motor were returned for evaluation.As stated in the text, the hand control was disposed of by the consumer's roommate and there was no evidence of fire on the two components that were returned.
 
Event or Problem Description
Alleges being reclined back in the chair when she smelled something burning and alleges the hand control caught on fire.Alleges she yanked the control from the chair and threw it outside and roommate threw the hand control away.
 
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Brand Name
PRIDE MOBILITY PRODUCTS
Common Device Name
ELECTRIC POSITIONING CHAIR
Manufacturer (Section D)
PRIDE MOBILITY PRODUCTS
401 york ave
duryea PA 18642
MDR Report Key8473967
Report Number2530130-2019-00034
Device Sequence Number1846870
Product Code INO
UDI-Device Identifier00606509400107
UDI-Public00606509400107
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K091578
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Model NumberLC525IM
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/28/2019
Supplement Date Received by Manufacturer03/28/2019
Initial Report FDA Received Date04/02/2019
Supplement Report FDA Received Date07/24/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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