MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. M51P RED BASE W/MK5 NX SPJ+ 9153642088; WHEELCHAIR, POWERED

Model Number M51PSEMIRED

Device Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

The left motor/gearbox assembly was returned for evaluation.Per the evaluation, brush noise was detected during the bench test.Additionally, when the brake cap was removed, it was identified that the brake assembly plastic was melted, but there was no external evidence of the melting.The underlying cause could not be determined after reviewing the documentation in this investigation.  .

Event Description

Brake assembly plastic was melted.

Manufacturer Narrative

Additional/updated information was added to reflect the left motor/gearbox assembly receiving an expanded evaluation.Per the expanded evaluation report, the complaint was not confirmed for the left motor/gearbox assembly producing an abnormal noise while driving.However, it was observed that there was wear to the brake disc and deformation present on the brake assembly consistent with excessive heat from improper disengagement of the brake disc.

Event Description

Brake assembly plastic was melted.

• Brand Name: M51P RED BASE W/MK5 NX SPJ+ 9153642088
• 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: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5965895
• MDR Text Key: 55215461
• Report Number: 3008262382-2016-00646
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• 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: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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