MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. PRONTO M41 RED BASE 9153645761; WHEELCHAIR, POWERED

Model Number M41FDR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Upon further review of previous decisions, it has been determined that should the reported malfunction recur, the device would be likely to cause or contribute to a death or serious injury.  there is no alleged injury associated with this event.This unit was manufactured in april 2012 and was listed on the invacare joystick recall of october 2013; there is no record with invacare of the joystick being replaced on this unit.Should additional information become available, a supplemental record will be filed.

Event Description

Dealer reported to invacare technician that the m41fdr power chair is surging.No alleged injury.

• Brand Name: PRONTO M41 RED BASE 9153645761
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou jiangsu 21512 1; CH 215121
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6150821
• MDR Text Key: 62202737
• Report Number: 3008262382-2016-00657
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M41FDR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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