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

Model Number	JAZZY AIR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made 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
Alleges sitting in chair when the bolts on the armrest broke and customer fell out of chair.
Additional Manufacturer Narrative
The seat was returned for evaluation.The right side armrest slide screws were fractured.It is likely the armrests were used improperly for load bearing/transfer purposes.
Event or Problem Description
Alleges sitting in chair when the bolts on the armrest broke and customer fell out of chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; n/a; duryea PA 18642
• MDR Report Key: 7177817
• Report Number: 2530130-2018-00003
• Device Sequence Number: 1067313
• Product Code: ITI
• UDI-Device Identifier: 00606509100069
• UDI-Public: 00606509100069
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 64