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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 LC358XXL
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/16/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The "patient identifier" has not been provided.The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
 
Event or Problem Description
Alleges the remote sparked and caught on fire.Customer was able to put it out but did call the fire department.
 
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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 Key12225888
Report Number2530130-2021-00081
Device Sequence Number5244604
Product Code INO
UDI-Device Identifier00606509400305
UDI-Public00606509400305
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K070950
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/23/2021
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 NumberLC358XXL
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2021
Initial Report FDA Received Date07/26/2021
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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