Catalog Number 1105000026 |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
|
|
Event Description
|
This report summarizes 1 malfunction event, where it was reported the device experienced steer mechanism is difficult to engage/disengage.There was no patient involvement.
|
|
Event Description
|
This report summarizes 3 malfunction events, where it was reported the device experienced steer mechanism is difficult to engage/disengage or brakes cannot be engaged.There was no patient involvement.
|
|
Manufacturer Narrative
|
The number of events has been updated to include an event previously reported on mfr report # 0001831750-2024-00264 following the completion of an investigation.
|
|
Search Alerts/Recalls
|