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

Model Number JAZZY PASSPORT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 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.

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 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
• Type of Device: POWERED WHEELCHAIR
• 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 ; 5706024056
• MDR Report Key: 8596405
• MDR Text Key: 144597136
• Report Number: 2530130-2019-00052
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization