MAUDE Adverse Event Report: PERMOBIL AB (PAB) 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); Injury (2348)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Reports received claim the end-user had sustained a fracture to their tibia, but it was unknown how the injury was sustained or if the injury was sustained during use of the wheelchair.Reports provided claim the wheelchair has been evaluated and was found to be operating according to specification.It was reported the end-user has healthcare aids who supervise the patient at home, and there is an acknowledgment among the aids that the "stand" function on this device should not be used.Reporter in this case stated no parties could confirm the injury sustained was caused as a result of using the wheelchair or use of the stand function, but only that serious injury somehow has occurred and was presumed to have occurred while using the wheelchair.As device was found to be fully operational and no reports or claims were made of the device having contributed to the event, permobil is unable to determine a root cause.The reporter has speculated if the injury was sustained while operating the device, the most probable cause would be use error by inadvertently activating the stand feature.In effort to mitigate any accidental use of the stand feature on the wheelchair, permobil has provided recommendation as to how to disable the stand function until end-user is approved, by their physician, to continue the use of the stand feature.The dhr was reviewed and device met specification prior to distribution.

Event Description

Permobil ab received a report of the end-user having sustained a serious injury consisting of a broken leg.Reporter in this case could not confirm the end-user actually sustained serious injury using the wheelchair, but only that serious injury somehow has occurred.

• Brand Name: F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86102 3; SW 861023
• Manufacturer (Section G): PERMOBIL AB; per uddens vag 20; timra, 861 2 3; SW 861 23
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, tn ; 7360925451
• MDR Report Key: 10460550
• MDR Text Key: 204598770
• Report Number: 1221084-2020-00042
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2017
• 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