MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWERED WHEELCHAIR

Model Number M300

Device Problem Detachment Of Device Component (1104)

Patient Problems Abrasion (1689); Fall (1848)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Investigation revealed that the root cause of this failure mode is linked to "improper service / maintenance".The original dealer had performed an improper installation of the friction brake kit.As a result, the front right fork had detached from the chassis and patient having not been wearing a positional belt fell out of the product and sustain injury.The wheelchair has been evaluated and the servicing dealer has been supplied the spare parts needed to repair the device back to factory specification.The original dealer technician, who performed service to the fork assembly linked to this failure is no longer employed by this dealer.Both dealerships were made aware of the improper dealer service has occurred and recommendation was made to the branch manager to facilitate training for all technician.The patient was informed to always wear a positional belt as required when occupying the wheelchair.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

The dealer reported that the front right fork and caster detached from the wheelchair.As a result, the client fell from the wheelchair and obtained abrasions to a previous toe injury.

• Brand Name: PERMOBIL M300
• 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: shawn waynick ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 7565672
• MDR Text Key: 109974104
• Report Number: 1221084-2018-00033
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M300
• 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: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2015
• 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: 88