MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL C300; POWERED WHEELCHAIR

Model Number C300

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/22/2016

Event Type  Injury  

Manufacturer Narrative

Permobil (b)(4) received call from end-user reporting as they were driving at speed, the chair stopped suddenly, without warning, thrusting the end-user forward in the seating due to momentum.When this occurred, the end-user fractured their left femur.It is believed the fracture was the result of the end-users pre-existing condition of oi, while being restrained in the seating via a positioning belt, caused the femur to fracture due to stress.An inspection of the chair was performed and it was found that a circuit board responsible for drive control communication had become loose from its mounting point.With this loss of connection, the electronics sensed the signal loss and as per design, brought the chair to a controlled stop.There was not an interruption in power, but rather a rapid controlled stop.Upon re-seating of the circuit board, unit was op-tested with no further issues being noted.It is unclear as to the cause of the circuit board to have become loose as this is not a known reported event.It is presumed that vibration of the chassis due to variances in terrain, over time, caused the loosening on the setting of the board to its mounting point.The dhr was reviewed and unit was found to have been built according to specification.Inspected by permobil representative.

Event Description

Received report that as end-user was driving at speed, the unit allegedly shut down stopping suddenly.Reports are end-user suffered a broken left femur as result of this event.Accounts are end-user was traversing through a train station traveling at approximately 9km/h when the chair reportedly lost power causing the unit to stop abruptly.Reports are end-user was wearing a positioning belt when this incident occured and remained secured in the seating.It is believed the injury was caused when the unit allegedly stopped, quickly thrusting the end-users body forward due to momentum.With the end-user being secured to seating via the positioning belt, combined with her pre-existing diagnosis, caused the femur bone to fracture due to stress.

• Brand Name: PERMOBIL C300
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 861 2 3; SW 861 23
• 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 37090 ; 8007360925
• MDR Report Key: 6171598
• MDR Text Key: 62315011
• Report Number: 1221084-2016-00052
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K041219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C300
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2015
• 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 Age: 27 YR
• Patient Weight: 18