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

Model Number	JAZZY PASSPORT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" has not been provided.The device has not yet been made available for evaluation.Should further information or the device become available for evaluation, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges that his wife's rear tire on her unit got a flat, his wife tried to drive the unit and the front caster wheel broke.Because of the alleged incident consumer missed her kidney dialysis and ended up in the hospital.
Additional Manufacturer Narrative
Only the rear drive wheels and front caster assembly were returned.Although neither drive tire leaked while inflated to 35psi and submerged in water, it is not within the intended use of the device to drive on a flat tire.It is likely this misuse led to the secondary damaging of the caster bearing and stem.
Event or Problem Description
Consumer alleges that his wife's rear tire on her unit got a flat.His wife tried to drive the unit and the front caster wheel broke.Because of the alleged incident consumer missed her kidney dialysis and ended up in the hospital.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 8596405
• Report Number: 2530130-2019-00052
• Device Sequence Number: 1639385
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011993
• 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): 07/16/2019

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 Number: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: Hospitalization