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

Model Number F5

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

Patient Problem Wound Dehiscence (1154)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Permobil was informed by the service provider that they had received the device for repairs with the end-user alleging that the device rolled away as he was attempting to transfer out of the seating.Client reported when this occurred, it caused him to lose balance and subsequently fall to the ground.The ensuing fall was reported to have caused wounds from a previous surgery to re-open which required medical intervention to address.Permobil representative performed an inspection of the device and confirmed the brake for the left drive wheel was no longer holding which allowed the drive wheel to spin freely when not given a drive command.Further inspection shown damages having been sustained to the brake release lever which forced the brake to be mechanically released, unable to hold the motor in place.Further inspection of the device shown multiple signs of impacts having been sustained indicating abuse/misuse by the end-user.The end-user was informed of the findings and instructed to use more care when operating the device and to ensure proper maintenance is performed.A parts quote was generated to replace the affected components that were damaged due to impacts.Upon completion of repairs, the device will be returned to the end-user.The dhr was reviewed and device met specification prior to distribution.

Event Description

Received report that as end-user was in process of performing a transfer out of the seating, the device allegedly rolled away causing the end-user to lose their balance and fall to the ground resulting in an injury requiring medical attention.

• Brand Name: PERMOBIL F5
• 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: 7573565
• MDR Text Key: 110224479
• Report Number: 1221084-2018-00037
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Weight: 116