MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; WHEELCCHAIR, POSITIONING. ELECTRIC

Model Number PLR3955LT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Laceration(s) (1946)

Event Date 06/16/2023

Event Type  Injury  

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 Description

Consumer alleges the chair wasn't reclining, allegedly made a clicking noise and he alleges the footrest wasn't coming up.

Manufacturer Narrative

The root cause of the event appears to be lift and recline (blue and green) actuator connectors were reversed.The evaluator matched the colored connectors and the chair functioned as designed.Based on the functional testing recorded in the device history record, the switching of the colored connectors occurred post final release.

Event Description

Consumer alleges the chair wasn't reclining, allegedly made a clicking noise and he alleges the footrest wasn't coming up.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCCHAIR, POSITIONING. ELECTRIC
• 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 avenue; duryea 18642 ; 8008008586
• MDR Report Key: 17209664
• MDR Text Key: 317950136
• Report Number: 2530130-2023-00084
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401500
• UDI-Public: 00606509401500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091578
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR3955LT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male