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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JUMAO HEALTHCARE EQUIPMENT TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL

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JUMAO HEALTHCARE EQUIPMENT TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TRSX58FBP
Device Problems Extender (806); Inadequacy of Device Shape and/or Size (1583)
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

End user is stating that the leg extenders are to short, with a broken ankle and knee she needs her leg to remain straight. End user is also stating that the leg extenders don't stay in place. Sometimes the wheels just spins and she can't get traction. The chair has been known to tip forward with her in it.

 
Manufacturer Narrative

The enduser gave serial number (b)(4). Based on the serial number it was concluded that this was not manufactured by invacare and an oem notification will be sent to the manufacture.

 
Event Description

End user is stating that the leg extenders are to short, with a broken ankle and knee she needs her leg to remain straight. End user is also stating that the leg extenders don't stay in place. Sometimes the wheels just spins and she can't get traction. The chair has been known to tip forward with her in it.

 
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Brand NameTRANSPORT 20 IN X 16 IN 9153637574
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
JUMAO HEALTHCARE EQUIPMENT
jiashan OH
CH
Manufacturer (Section G)
JUMAO HEALTHCARE EQUIPMENT
jiashan OH
CH
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5250337
MDR Text Key32305586
Report Number1525712-2015-05513
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 12/29/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberTRSX58FBP
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2015
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

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