INVAMEX TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C//U240 9153653560; WHEELCHAIR, MECHANICAL
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Model Number TRSX50FBP |
Device Problem
Device Slipped (1584)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available a supplemental record will be filed.
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Event Description
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Dealer advised enduser stated was in the restroom and transferring and both wheel locks did not hold.
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Manufacturer Narrative
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Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for wheel locks that would not prevent wheel rotation.The hardware for the wheel locks is loose, which allow the locks to slight lateral movement of the locks.However, the wheel locks are still able to be fully engaged to prevent wheel rotation.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
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Event Description
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Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for wheel locks that would not prevent wheel rotation.The hardware for the wheel locks is loose, which allow the locks to slight lateral movement of the locks.However, the wheel locks are still able to be fully engaged to prevent wheel rotation.Dealer advised enduser stated was in the restroom and transferring and both wheel locks did not hold.
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