MAUDE Adverse Event Report: INVACARE TAYLOR STREET INVACARE PRONTO M51; WHEELCHAIR, POWERED

Model Number M51PSEMIRED

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported symptoms are consistent with those associated with joystick recall z-2270-2013 that was previously initiated by invacare on 06/04/2013.The serial number of the subject chair indicates that it was impacted by this recall.The recall was issued because invacare identified that there was an insufficient electrical connection between the joystick inductive and the pcb.The defect may result in unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of the power wheelchair.To correct the issue, the internal inductive connection to the pcb was changed from a mechanical crimped connection to a direct wire connection via a soldering process.Invacare sent an urgent patient safety notification letter to all customers affected by the recall.The customers were instructed to contact their wheelchair provider to have their joystick replaced.However, there is no record that joystick recall was ever done on this chair.On 09/03/2019, the subject joystick was returned to invacare.Based on its serial number, it was confirmed to be within the scope of the recall.The component was disposed, per the recall process.A replacement joystick was sent to the dealer to correct the issue.The subject chair was manufactured by invacare rehabilitation equipment co.(b)(4); however, they are no longer in business.Therefore, the mdr is being filed under invacare (b)(4), which also manufactured these chairs.The m51 has since been obsolete, as of november 2016.

Event Description

The dealer reported that the m51 power chair speeds up and slows down on its own, without any prompting from the joystick.

• Brand Name: INVACARE PRONTO M51
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9075440
• MDR Text Key: 203506855
• Report Number: 1525712-2019-00025
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M51PSEMIRED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2270-2013
• Patient Sequence Number: 1