MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

Model Number UNKNOWN

Device Problems Bent (1059); Device Tipped Over (2589)

Patient Problem No Information (3190)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

According to the customer vitalaire: ¿the patient was tilted backwards when she wanted to cross a pavement because the backrest moved down step by step.The tooth of the recliner backrest support in the right side was bent.The patient managed to avoid the fall by balancing herself on the opposite side.The chair was installed for the patient since (b)(6).No failure was noticed.The patient is (b)(6)." the action 2 is the same /similar to the myon which is manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in (b)(6).

Event Description

According to the customer vitalaire: "the patient was tilted backwards when she wanted to cross a pavement because the backrest moved down step by step.The tooth of the recliner backrest support in the right side was bent.The patient managed to avoid the fall by balancing herself on the opposite side.The chair was installed for the patient since (b)(6).No failure was noticed.The patient is (b)(6)." the action 2 is the same /similar to the myon which is manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in (b)(6).

• Brand Name: TRANSPORT 20 IN X 16 IN 9153637574
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5778533
• MDR Text Key: 49789440
• Report Number: 1525712-2016-02435
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2016
• 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
• Patient Age: 30
• Patient Weight: 75