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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL
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INVACARE TAYLOR STREET TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number MYON
Device Problem Defective Device (2588)
Patient Problem Fall (1848)
Event Type  malfunction  
Manufacturer Narrative
Due to a brake defect the patient fell from the wheelchair.The action 1 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
Due to a brake defect the patient fell from the wheelchair.The action 1 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).
 
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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 Key5390204
MDR Text Key36994618
Report Number1525712-2016-00270
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
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 01/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMYON
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/12/2016
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 Number1
Patient Age94
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