MAUDE Adverse Event Report: PERMOBIL PERMOBIL POWER WHEELCHAIR; WHEELCHAIR, POWERED

Model Number F3

Device Problems Device Alarm System (1012); Unintended Collision (1429); Unintended System Motion (1430); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2020

Event Type  Injury  

Event Description

Caller stated on (b)(6) 2020 while in (b)(6), the chair moved backwards on its own and did stop until it collided into the wall.An error message appeared "2f01".Caller reported incident to the mfr and national seating and mobility who did not evaluate the device due to scheduling issues.On (b)(6) 2020 the chair and the screen failed to operate.The caller informed the mfr who sent out an evaluator on (b)(6) named (b)(6).The master module used to control the chair and the screen was malfunctioning, however, the evaluator did not file the repair order through the warranty process which documents the incident for the mfr records.Additionally, caller is concerned the evaluation did not send the malfunctioning part to the mfr as advised by (b)(6) due to the evaluator repeatedly asking if he can throw the device away.Caller found during her research that permobil had prior issues with other device models malfunctioning and causing user injuries.

Event Description

Additional information received on 5/13/2020 from reporter for report number mw5093309.On (b)(6) 2020, caller reported experiencing another joystick error, identical to the one that occurred in (b)(6) 2020.Error code stated ¿2f01 jsm center joystick error¿.Caller also reported on (b)(6) 2020 the function button that controls the seat elevator, tilt, and recline functions were no longer illuminated in green.Instead they turned white and the chair did not respond to button activation.Caller is concerned the device will cause injury and would like to request an inspection of the manufacturing facility.

Event Description

Additional information received from reporter on (b)(6) 2020, for report number mw5093309.Reporter said yesterday, (b)(6) 2020 the power-seat elevator wheelchair makes a chirping sound similar to a whirling sound when you raise it up and down.She also said when she tries to tilt the seat forward and backward, it makes whirling and cricket sound.

• Brand Name: PERMOBIL POWER WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PERMOBIL
• MDR Report Key: 9763538
• MDR Text Key: 181628977
• Report Number: MW5093309
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: F3
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR