MAUDE Adverse Event Report: PERMOBIL AB PERMOBIL F5; POWERED WHEELCHAIR

Model Number F5

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Contusion (1787); Hematoma (1884)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation revealed that the root cause of this failure mode is contributed to "component failure".The patient was using the wheelchair outdoors when the right drive wheel assembly detached from the device.The end-user reported having suffered minor injuries as a result.An evaluation of the product confirmed the complaint noting the main hub bolt having broken off, allowing the drive wheel and hub assembly to detach itself from the motor shaft.A capa had been opened for this reported failure in order to identify cause and implement corrective measures to prevent recurrence.The failure was linked back to the supplier and related to an assembly error installing the wheel hub to the drive motor shaft.This issue that has since been corrected by the supplier and permobil continues to monitor for effectiveness.The risk for this failure to occur is low and the likely hood of injury to occur is also low.The suspect wheelchair was repaired and returned to the customer with no further reported issues being noted.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

Received report indicating the end-user was traveling down a sidewalk from home to work, the right drive wheel was reported to have suddenly detached.This allegedly caused the device turn hard to the left, eventually pinning the end-users right arm against a guard rail.Reports indicate the end-user suffered hematomas and bruised muscles in their right arm.It was not reported the end-user had sought medical intervention.

• Brand Name: PERMOBIL F5
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB; per uddens vag 20; timra, 86123 ; SW 86123
• Manufacturer (Section G): PERMOBIL AB; per uddens vag 20; timra, 86123 ; SW 86123
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 9317739
• MDR Text Key: 184117822
• Report Number: 1221084-2019-00050
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1