Catalog Number 1115000026 |
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.11 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device is 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 12 malfunction events, where it was reported the devices experienced brakes cannot be engaged, steer mechanism is difficult to engage/disengage, or brakes difficult to engage/disengage.There was no patient involvement.
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Manufacturer Narrative
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The device that was pending was evaluated and it was determined the device experienced brake/steer pedal is inoperable, which is not reportable.Section h codes have been updated.Because of this, the number of reported events has been changed from 12 to 11.
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Event Description
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This report summarizes 11 malfunction events, where it was reported the devices experienced brakes cannot be engaged, steer mechanism is difficult to engage/disengage, or brakes difficult to engage/disengage.There was no patient involvement.
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Search Alerts/Recalls
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