PERMOBIL POWER WHEELCHAIR F3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for PERMOBIL POWER WHEELCHAIR F3 manufactured by Permobil.

Event Text Entries

[181628977] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093309
• MDR Report Key: 9763538
• Date Received: 2020-02-26
• Date of Report: 2020-02-26
• Date of Event: 2020-01-03
• Date Added to Maude: 2020-02-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERMOBIL POWER WHEELCHAIR
• Generic Name: WHEELCHAIR, POWERED
• Product Code: ITI
• Date Received: 2020-02-26
• Model Number: F3
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PERMOBIL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-26