MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

Model Number	PLR990IL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device become available or further information become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges the back broke off of the chair and the end user allegedly fell out.
Event or Problem Description
Provider alleges the back broke off of the chair and the end user allegedly fell out.
Additional Manufacturer Narrative
The device was returned and evaluated.The back did not break off.The visual and mechanical evidence indicates the kd securement hardware was not utilized during back assembly.Improper/incomplete back installation post final release.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11945993
• Report Number: 2530130-2021-00055
• Device Sequence Number: 1153571
• Product Code: INO
• UDI-Device Identifier: 00606509401203
• UDI-Public: 00606509401203
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K091578
• 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): 07/15/2021

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: PLR990IL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/19/2021
• 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: Other