Catalog Number 1115000030 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.38 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 40 malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage, steer mechanism is difficult to engage/disengage or brakes cannot be engaged.There was no patient involvement.
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Manufacturer Narrative
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1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.1 device that was pending was evaluated and it was determined the device experienced brake/steer pedal is inoperable; must use alternate pedal, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 40 to 39.
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Event Description
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This report summarizes 39 malfunction events, where it was reported the devices experienced brakes difficult to engage/disengage, steer mechanism is difficult to engage/disengage or brakes cannot be engaged.There was no patient involvement.
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Search Alerts/Recalls
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