MAUDE Adverse Event Report: INVACARE TAYLOR ST. AVIVA FX POWER CHAIA; POWERED WHEELCHAIR

Model Number NA:IFX-20C

Device Problem Unexpected Shutdown (4019)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

This record is being filed in an abundance of caution.The end user alleges this has happened on 3 occasions, it is unclear what malfunction, if any has caused the 3 incidents.Invacare has requested the return of the aviva fx powerchair.Multiple attempts have been made to the dealer to process the return without success.The end user originally stated no medical treatment was required but later stated that he is treating the wound at home.Additional information regarding the injuries and the treatment has been repeatedly requested without success.A record is being filed for each event.

Event Description

The customer fell out of the chair on 3 (three) separate occasions.The end user stated that his stump incision was opened with each incident and required at home "wound care".The end user is a double amputee, it is unclear if the same stump was injured in all 3 cases.He related the injury now takes longer to heal due to repeated incidents.It is unknown if treatment by a healthcare professional was required.Repeated inquiries were made to obtain further information without success.It is unknown what caused the end user to get thrown from the chair.

Manufacturer Narrative

The aviva fx powerchair was returned for evaluation.All the chairs drive and seating functions were tested with no issues observed.It was noted that the power module and gyro firmware did not have the latest update.The chair¿s error history log did show multiple 7:9 flash code errors indicating an overvoltage condition was experienced.This can be triggered by highly charged batteries and or regenerative braking.Regenerative breaking is when energy is recovered typically when going downhill that recharges the batteries.The error can be cleared by letting the batteries return to a lower voltage.It is normal function of the chair come to a stop when an error code is detected, which could be unexpected to the end user.It was also confirmed that the aviva had a functioning seat positioning strap that the end user chooses not to use.The owner¿s manual 60101916 lists the following warnings and instructions: danger! risk of death or serious injury: not wearing your seat positioning strap could result in death or serious injury.-always wear your seat positioning strap.Your seat positioning strap helps reduce the possibility of a fall from the wheelchair.The seat positioning strap is a positioning belt only.It is not designed for use as a safety device withstanding high stress loads such as auto or aircraft safety belts.If signs of wear appear, seat positioning strap must be replaced immediately.

Event Description

The customer fell out of the chair on 3 (three) separate occasions.The end user stated that his stump incision was opened with each incident and required at home "wound care".The end user is a double amputee, it is unclear if the same stump was injured in all 3 cases.He related the injury now takes longer to heal due to repeated incidents.It is unknown if treatment by a healthcare professional was required.Repeated inquiries were made to obtain further information without success.It is unknown what caused the end user to get thrown from the chair.

• Brand Name: AVIVA FX POWER CHAIA
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR ST.; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 12370526
• MDR Text Key: 268239541
• Report Number: 1525712-2021-00013
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:IFX-20C
• Device Catalogue Number: IFX-20C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male