MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3; POWERED WHEELCHAIR

Model Number F3

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Discomfort (2330)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.The reported failure involves the recline mounting bracket having detached from the seat frame.The suspect component has been returned for analysis.In our initial review the suspect component appears to have been installed according to specification and evidence suggest possible heavy impact or forward forces were applied to the backrest assembly.Permobil is attempting an opportunity to evaluated the wheelchair and interview the patient.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

Reports that the recline actuator with the bracket detached from the wheelchair.As a result the backrest fell rapidly.The patient reported falling backwards out of the seat and struck her head on the floor.No medical attention sought.Patient reports soreness to head and back.

Manufacturer Narrative

Investigation revealed that the root cause of this failure mode is linked to an extraordinary event.Inspection evidence suggest that substantial forces were applied to the backrest assembly at an unknown time while the patient was in possession of the device.This apparent impact event having gone unreported by the patient/family had compromised the recline actuator mounting bracket and hardware having activated a safety feature built into the suspect component.Consequently, the patient continued to use the product increasing the risk for additional damages or potential for serious injury to occur.In this incident, medical attention was not necessary as no serious injury occurred.Permobil sought to obtain a direct confession from the patient regarding specific details concerning impact damage in connection to the backrest assembly and have been unsuccessful.Therefore, permobil has requested that the patient be made aware of our assessment for the cause of this failure being linked to unusual and extreme forward forces applied to the backrest assembly.The owner's manual warns users to stop use of the product, if damages or a malfunction should occur seeking service as soon as possible.The labeling for the product will be revisited with the patient to bring awareness and ensure intend use is observed to mitigate further risk.The dealer has been supplied new replacement components and the wheelchair has been repaired and returned to the patient.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

• Brand Name: PERMOBIL F3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7907556
• MDR Text Key: 121714184
• Report Number: 1221084-2018-00054
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 121