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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE TAYLOR STREET PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED
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INVACARE TAYLOR STREET PRONTO M41 BLUE BASE 9153645762; WHEELCHAIR, POWERED Back to Search Results
Model Number PRONTO M41
Device Problem Material Deformation (2976)
Patient Problem Discomfort (2330)
Event Date 09/14/2015
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available for the patient a supplemental record will be filed.
 
Event Description
Client made contact with repair service advising that a clip on the backrest panel and snapped and that the chair felt uncomfortable.When technician inspected the chair it was noted that the center pivot/mounting post had sheared at the top of the post around the weld.
 
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Brand Name
PRONTO M41 BLUE BASE 9153645762
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 Key5130241
MDR Text Key27874308
Report Number1525712-2015-04771
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Report Date 09/23/2015
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 NumberPRONTO M41
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/06/2015
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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