MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL F3; POWERED WHEELCHAIR

Model Number F3

Device Problems Break (1069); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/31/2022

Event Type  Injury  

Event Description

Permobil ab received report claiming as the end-user came to a quick stop while driving their power wheelchair, one of the backpack hooks mounted on to the back rest broke allowing the backpack to fall to the ground.Reports indicate the backpack contained enteral feeding pumps inside and when the backpack fell the tube connected to the end-user was pulled from their stoma requiring medical intervention to resolve.

Manufacturer Narrative

Reports provided claim one of the 2 backpack hooks mounted to the back rest of the wheelchair had broken allowing the backpack holding 2 enteral feeding pumps to fall to the ground.Reports claim the feeding tube was attached to the end-user at the time and with the backpack falling, yanked the feeding tube out of the end-user's stoma resulting in an undisclosed injury requiring medical intervention to address.Photo evidence confirmed the failure of the aluminum hook having broken just below where it protrudes from the mounting plate.Photos provided also appear to indicate the backpack was only being held by 1 hook at a time as opposed to evenly distributing the weight of the backpack.Further review of photos indicates the remaining hook is distended and bent which would indicate excessive weight being applied or physical damages having been applied due to impacts.Permobil has recommended the hooks be replaced with new and instruction provided of the need to evenly distribute the weight by using both hooks.Permobil has no recorded history of this type of failure mode having been reported but will continue to monitor through trend analysis.The dhr was reviewed, and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL F3
• 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 86123
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15013195
• MDR Text Key: 295864327
• Report Number: 1221084-2022-00012
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K143180
• 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: 07/14/2022

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: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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
• Patient Sex: Prefer Not To Disclose