MAUDE Adverse Event Report: PERMOBIL AB (PAB) 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); Limb Fracture (4518)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Permobil (b)(6) was contacted by an occupational therapist from a rehab facility reporting during a general care evaluation for their patient, it was discovered they had sustained a fracture to one of their tibia's.Interviews conducted with the end-user claim having no knowledge of when the injury occurred or how it could have occurred.The rehab facility reported having conducted an internal investigation, finding the power wheelchair to be fully operational with no issues being found.Although unable to confirm, it was the operational therapist's theory the end-user sustained the injury while using the devices standing feature as the injury sustained was at the same level to where the devices knee block assembly was positioned for the end-user.The ot made mention that the knee block was positioned correctly for the end-user but speculated the end-user may not have had their feet properly positioned before initiating an un-supervised standing sequence.With the information provided, permobil is unable to reach a determination as to possible root cause without speculation.Permobil will continue to monitor and if any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Permobil ab received report claiming while performing general care, the nursing staff found the end-user had sustained a fracture of the tibia.In the facility's internal evaluation, it was identified that operation of wheelchairs standing feature as a possible cause since the fracture is at the level of the knee support.

• Brand Name: PERMOBIL F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86123 ; SW 86123
• MDR Report Key: 12642934
• MDR Text Key: 280746768
• Report Number: 1221084-2021-00035
• Device Sequence Number: 1
• Product Code: IPL
• Combination Product (y/n): N
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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: 09/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2020
• 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