MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number M3

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Nervous System Injury (2689)

Event Date 06/02/2019

Event Type  Injury  

Manufacturer Narrative

Permobil received a medwatch report (mw5092890) claiming an injury having occurred as a result of an alleged failure of the devices backrest.Claims received indicate as the end-user was in the process of reclining, the back of the seating was alleged to have fallen off reportedly ejecting the end-user from the seating to the ground.Reports indicate the end-user has since had increased pain with reports of increased difficult with their bowel program.Report indicates the end-user received x-rays and an mri, but the results were not disclosed.The dhr was reviewed and the device met specification prior to distribution.Review of device history indicates permobil has not received any reports or inquiries from the service provider since the device was distributed.Inquiries to the service provider were placed to which it was reported they had not received any forms of communication from the end-user since the initial delivery of the device in january, 2019.Service provider stated they would attempt to establish contact with the end-user to inquire as to the need for service.At this time, permobil has been unable to obtain any additional information relating the malfunction that may have contributed to this reported event.Permobil will continue to investigate and if any new information is received, a flow-up report will be submitted.

Event Description

Received medwatch report alleging while the end-user was reclined in their device, the back of the chair fell off and the end-user was ejected out of the seating.Reports having been injured as a result.

Manufacturer Narrative

Permobil was contacted by the end-user to inquire about their device.The end-user described the seating was in approximately 10-15° of tilt when suddenly the entire seating fell backwards.The sudden jolt of the seating falling back reportedly caused the end-user to fall over to the side, but they were able to catch themselves and remain positioned in the seating.End-user claimed having an mri performed (as noted in the original report) and stated you could see a difference from a previous mri done prior to the incident.End-user didn't go into specifics as a physical injury other than having received increased inflammation in their neck and spine resulting in a signal loss in the nervous system.End-user reports he is not currently suffering any long term effects after the incident.The end-user was provided a new permobil m5 corpus and the suspect m3 corpus was returned to permobil for inspection and evaluation.Evaluation of device found all seat functions to be fully operational with no notable malfunctions or physical defects.All seat functions were tested to full range of operation at maximum seating capacity (300#) with device operating as per design.Permobil was unable to confirm a product failure having occurred therefore, is unable to reach a determination as to possible root cause of the reported event.The dhr was reviewed and device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL M3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon, tn
• MDR Report Key: 9900409
• MDR Text Key: 191662825
• Report Number: 1221084-2020-00017
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (y/n): N
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 98