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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET M61P BLUE BASE 9153653450; WHEELCHAIR, POWERED
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INVACARE TAYLOR STREET M61P BLUE BASE 9153653450; WHEELCHAIR, POWERED Back to Search Results
Model Number M61
Device Problems Unintended System Motion (1430); Sticking (1597); Defective Component (2292)
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
Provider states the joystick is defective.Provider states the joystick is sticking and turns on its own, when sitting still in the chair it will creep forward and when consumer is moving forward it will turn.No additional information provided therefore no protocol questions asked.
 
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Brand Name
M61P BLUE BASE 9153653450
Type of Device
WHEELCHAIR, POWERED
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 Key5187382
MDR Text Key30271533
Report Number1525712-2015-05090
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 10/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberM61
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/07/2015
Initial Date FDA Received10/29/2015
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
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