MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIP POWERED WHEELCHAIR; 890.3860

Model Number M41SR20B

Device Problem Unintended Movement (3026)

Patient Problem No Patient involvement (2648)

Event Type  malfunction  

Event Description

It was reported that as end user reached into the kitchen cabinet she put the m41sr20b power wheel chair in reverse but the chair moved faster than she anticipated.End users hand was caught in the cabinet and she sustained a pinch to her left hand.No medical intervention was reported.

• Brand Name: POWERED WHEELCHAIR
• Type of Device: 890.3860
• Manufacturer (Section D): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer (Section G): INVACARE REHABILITATION EQUIP; no.435 xieyu street; suzhou industrial park; jiangsu, p.rc. 2150 26; CH 215026
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3867292
• MDR Text Key: 21312848
• Report Number: 3008262382-2014-00071
• 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: Consumer
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M41SR20B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2014
• 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
• Patient Outcome(s): Other