MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED

Model Number M41SR20B

Device Problems Crack (1135); Unstable (1667)

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

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Dealer states that the user called him and stated that his seat was wobbly and when the dealer arrived he discovered that where the seat post goes into the base frame it has cracked.

Manufacturer Narrative

Additional/updated information was added to reflect the frame assembly being returned to the manufacturer for evaluation, and subsequent testing verified the complaint.However, the underlying cause could not be determined after reviewing the documentation in this investigation.Per the initial evaluation, the coved washer that mounts the seat post to the frame had broken from the post receiver tube.An expanded evaluation was performed.The expanded evaluation report confirmed that the seat post receiver tube was broken at the top, and there was corrosion present around the broken area.Fields were updated accordingly.

Event Description

Dealer states that the user called him and stated that his seat was wobbly and when the dealer arrived he discovered that where the seat post goes into the base frame it has cracked.

• Brand Name: POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
• 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: 5774974
• MDR Text Key: 49139655
• Report Number: 3008262382-2016-00577
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M41SR20B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2016
• 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
• Patient Weight: 118