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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TISPORT, LLC AERO Z; WHEELCHAIR ANTI-TIP
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TISPORT, LLC AERO Z; WHEELCHAIR ANTI-TIP Back to Search Results
Model Number AERO Z
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2018
Event Type  malfunction  
Manufacturer Narrative
No injury was reported in this event.There is a risk of serious injury in the case of a failure of the anti-tips while engaged.The returned samples of the anti-tips were tested, along with samples from the then-current lot and of a different lot.The results of a combination of internal and external/third-party testing indicates that the material of the anti-tip tube used on the construction of this chair was softer and weaker than the design specified.
 
Event Description
The provider claims the therapist tested the anti-tips before getting the patient in, and as a result of the test the anti-tip tubes bent.
 
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Brand Name
AERO Z
Type of Device
WHEELCHAIR ANTI-TIP
Manufacturer (Section D)
TISPORT, LLC
2701 w court st
pasco WA 99301
Manufacturer Contact
brian english
2701 w court st
pasco, WA 99301
5095866117
MDR Report Key7820455
MDR Text Key118552326
Report Number3032618-2018-00006
Device Sequence Number1
Product Code IMR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAERO Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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