MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number	GO CHAIR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges a strange odor was coming from the chair when they plugged in the charger.Provider also alleges the batteries started leaking.
Additional Manufacturer Narrative
The "date of event" and "device manufacture date" were updated.Only the battery box and 17ah batteries were returned.The returned batteries appeared to have vented (bloated).The charger was not retuned.Although an exact cause can not be determined, the most likely cause would be heat build-up from overcharging.- attachment: [5513 rpe signed.Pdf].
Event or Problem Description
Provider alleges a strange odor was coming from the chair when they plugged in the charger.Provider also alleges the batteries started leaking.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10074701
• Report Number: 2530130-2020-00052
• Device Sequence Number: 14178196
• Product Code: ITI
• UDI-Device Identifier: 00606509100007
• UDI-Public: 00606509100007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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 Number: GO CHAIR
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other