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

Model Number F5

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Permobil received report indicating an injury having occurred to the end-user as they were operating their mobility device.Report indicated the end-user suffered fractures to both left and right tibia's, but report did not go into detail as to the circumstances surrounding the event nor the probable cause other than they believe the device malfunctioned some how to have caused it.Since receipt of report, both permobil and the service provider have been attempting to contact the end-user and their family in order to gather more information as to the circumstances surrounding the claim and to request access to the device for evaluation.At this point, permobil has been unable to make contact with anyone with knowledge of the alleged event.Permobil will continue to investigate and upon receipt of new information, a follow-up report will be submitted.The dhr was reviewed and the device met specification prior to distribution.

Event Description

Received report alleging an undisclosed malfunction having occurred with the device which caused the end-user to have suffered a broken leg.

• 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: 8795917
• MDR Text Key: 151221547
• Report Number: 1221084-2019-00032
• Device Sequence Number: 1
• Product Code: ITI
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• 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: 84