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

Model Number	QUANTUM Q6 EDGE HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Laceration(s) (1946)
Date of Event	01/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should further information of the device become available, a follow-up report will be issued.
Event or Problem Description
Consumer alleges he was asleep in his chair and in the middle of the night the back allegedly broke away and he allegedly fell to the floor.
Additional Manufacturer Narrative
The right side seat base plate interface was torn/broken.The left side back to base slot block (mec121721), spacer and associated hardware were missing.With this, it is likely the seat interface was compromised on the opposing attached side due to these critical missing components.The device history record indicates the seating system was built properly in 2018.Although it is unknown why these parts were missing, visual inspection indicates adjustments to the seat/back depth were made post final release suggesting the interface components were loosened during these adjustments.Further, the seating system was subjected to heavy incontinence.It is unknown if this played any roll in the failure.
Event or Problem Description
Consumer alleges he was asleep in his chair and in the middle of the night the back allegedly broke away and he allegedly fell to the floor.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: 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 ; 8008008586
• MDR Report Key: 15122909
• Report Number: 2530130-2022-00067
• Device Sequence Number: 7267690
• Product Code: ITI
• UDI-Device Identifier: 00606509200059
• UDI-Public: 00606509200059
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: QUANTUM Q6 EDGE HD
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2018
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male