MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problems Mechanical Problem (1384); Unintended System Motion (1430); Unintended Movement (3026)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The end-user claimed while attempting to reposition the seating via the switchbox, when initiating a tilt function, the seating was alleged as having started a stand function.End-user alleged when releasing the button on the switchbox, the seating continued to operate without control into a standing positioning.End-user claimed having attempted to hit every button to stop, but the seating continued to stand until the end-user reported losing positioning and fell forward out of the seating into some nearby bushes.Reports indicate the end-user sustained minor scratches and abrasions that did not require medical intervention.Review of device history indicated previous reports of operational anomalies that were determined to have been caused by the device electronics having been exposed to water.Replacement components were ordered and installed approximately 1.5 months prior to this reported event.After report of this event, the device has been removed from service and end-user provided with a new power wheelchair.An inspection and evaluation of the device was performed by permobil representatives who found the device to be fully operational with no indications or evidence of a failure or deviation in functionality having occurred.At this time, permobil was unable to duplicate any unintentional operation as alleged nor find any evidence to substantiate a failure has occurred.Permobil has requested the device be returned to the manufacturing site for further evaluation in effort to determine a potential root cause.If/when upon completion of evaluation, any new information or findings are discovered, a follow-up report will be submitted.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Received report where end-user alleged the seat functions moved on their own which caused the seating to go into a stand.This action reportedly caused the end-user to lose positioning and fall out of the seating.No serious injuries occurred as a result.

• Brand Name: PERMOBIL F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 11347666
• MDR Text Key: 232555101
• Report Number: 1221084-2021-00005
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 116