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

Model Number F5 CORPUS VS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519); Unspecified Musculoskeletal problem (4535)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

The device was evaluated by the local service provider and was found to be fully operational with no signs of a malfunction having occurred.The end-user did not make any claims or allegations of the device having malfunctioned in any way to have contributed to the event but relayed not knowing how the device having fallen to the side.End-user reported it was raining and the surface was very wet and slick.With the testimony presented from the end-user, the reporter speculates the most likely cause was inadvertent use-error in maneuvering the device close to an edge of a ramp, or the rainy conditions allowing the device to lose traction.With the device evaluation finding no signs of a malfunction having occurred, permobil is unable to reach a determination as to possible root cause without speculation.The dhr was reviewed with device being found to have met specification prior to distribution.

Event Description

Received report claiming as the end-user was leaving a restaurant in rainy conditions, while descending a ramp, the device reportedly fell over on to its side.This resulted in an injury requiring medical intervention.

• Brand Name: PERMOBIL F5 CORPUS VS
• 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: ivan fernandez ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 17012436
• MDR Text Key: 316049717
• Report Number: 1221084-2023-00009
• Device Sequence Number: 1
• Product Code: IPL
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose