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

Model Number F5

Device Problems Material Separation (1562); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/05/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.The patient has been uncooperative and has not allowed permobil access to the wheelchair or their home environment in order to investigate the alleged claim(s).The patient and the wheelchair have been under evaluation by the servicing provider, patient's insurer and home modifications specialist in conjunction with permobil from repeat caster fork failures determined to be related to "neglect/abuse".The patient's initial weight was listed at (b)(6) in 2016 and is now possibly over the weight limit for the device.The patient has been requested to contact their physician and supply an updated weight.The suspect wheelchair used by the patient is rated at 300 lbs.Maximum user weight.The patient has been unwilling to provide an updated weight and stated that his physician refuses to weigh him.The servicing provider has located another manufactures device that exceeds the 300 lb.Weight capacity that will be more suitable for the patient's weight class.It is unknown whether the patient is willing to accept a replacement wheelchair at this time.Furthermore, the patient has never reported that the wheelchair has tipped over or that they have experienced unintended movement or sustained any injury.This coincides with both permobil's and the servicing provider's records.In conclusion, permobil is unable to validate any additional facts at this time.If further information is discovered and/or issues can be resolved, a follow-up report will be submitted and contain any missing information not supplied in this report.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

The patient reported (medwatch report mw5083243) that on (b)(6) 2018, caster fork(s) broke causing the wheelchair to allegedly tip over.The patient also reported three other incidents where the wheelchair allegedly drove by itself without a command being given.First incident (date unknown) the device ran him into the side of his van; second incident (date unknown) the device ran him into a hedge; and the third incident (date unknown) the device rammed the patient's left knee into a large tool box, severely cutting his knee.The patient reported having scars on his knee and being daily in pain from this injury.The patient reports having many photos of broken caster forks and voice recordings available.

Manufacturer Narrative

The original complaint investigation had been placed on-hold june 2019 not having the ability to further pursue alleged claims of a device malfunction, due to the patient refusing to cooperate with permobil or the service provider.The servicing dealer reported to permobil of the plan to bring the patient another non-permobil wheelchair best suitable for the patients' heavier weight class.After this service was provided to the patient, the dealer took possession of the suspect permobil wheelchair.The dealer received the wheelchair from the patient in a poor diminished unusable state and the cause is being attributed to user neglect / abuse.The wheelchair was partially disassembled and essential components removed by the patient.The device was returned incomplete to permobil in "as is" condition on october 4, 2019 and confirmed to be out of specification for safe and effective use.The wheelchair in this neglected condition would require substantial servicing, if repaired back to factory specs.The device was operationally tested (drive & seat functions) and found fully functional without an issue being noted.The wheelchairs control system log was also reviewed for error codes and there was no supportive evidence of an electronic issue that would validate the allegation that the device has repeatedly drove by itself.Therefore, we are unable to confirm, recreate or further investigate the patients complaint.The patient was provided another wheelchair and the dealer received partial credit for the suspect device.As an end result, no further corrections or corrective actions can be taken.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

• Brand Name: PERMOBIL F5
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 8363159
• MDR Text Key: 136916998
• Report Number: 1221084-2019-00011
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 135