|
Model Number PROX4S |
Device Problem
Break (1069)
|
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 left cross brace is broken at the pivot point.
|
|
Manufacturer Narrative
|
Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, broken frame/weld.Tubing broke at center hole.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was received in two pieces.The cross brace was broken at the hole where the two cross braces are bolted together.One of the pieces was received with a foreign piece of tubing wedged inside of it.The cross brace also had several areas with heavy scratches and paint loss.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the broken cross brace.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.
|
|
Event Description
|
Product was returned for evaluation.The return fields in oracle state: standard wheelchairs.Frame, broken frame/weld.Tubing broke at center hole.Product received expanded evaluation.The expanded evaluation report states: visual inspection- the cross brace was received in two pieces.The cross brace was broken at the hole where the two cross braces are bolted together.One of the pieces was received with a foreign piece of tubing wedged inside of it.The cross brace also had several areas with heavy scratches and paint loss.Conclusions- utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the broken cross brace.Provider states the left cross brace is broken at the pivot point.
|
|
Search Alerts/Recalls
|
|
|