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

Model Number	JAZZY AIR 2
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	05/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer alleges she stopped the chair in the hall.When she got up the button hadn't pressed so she was standing and went to make sure the chair was as low as it goes so she could get back in easily.She alleges that she pushed up to lower it and the chair allegedly went forward into the back of her legs and over her left foot.She allegedly couldn't pull her foot out and had to back over it.At which point her legs allegedly gave out and when she allegedly reached behind her to grab the arm of the chair she only reached the joystick area which allegedly bent down and she allegedly fell onto the floor.
Additional Manufacturer Narrative
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
Consumer alleges she stopped the chair in the hall.When she got up the button hadn't pressed so she was standing and went to make sure the chair was as low as it goes so she could get back in easily.She alleges that she pushed up to lower it and the chair allegedly went forward into the back of her legs and over her left foot.She allegedly couldn't pull her foot out and had to back over it.At which point her legs allegedly gave out and when she allegedly reached behind her to grab the arm of the chair she only reached the joystick area which allegedly bent down and she allegedly fell onto the floor.
Additional Manufacturer Narrative
Device functioned as designed upon return.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york avenue; duryea 18642 ; 8008008586
• MDR Report Key: 17412605
• Report Number: 2530130-2023-00114
• Device Sequence Number: 17901898
• Product Code: ITI
• UDI-Device Identifier: 00606509100229
• UDI-Public: 00606509100229
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143383
• Number of Events Summarized: 1
• 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,Followup
• Report Date (Section B): 09/21/2023

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 AIR 2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female