Model Number 1460-000-000 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2021 |
Event Type
malfunction
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Event Description
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This report summarizes 6 malfunction events, where it was reported the devices brakes cannot be engaged.There was no patient involvement.
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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.4 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.There was no remedial action taken.This device is not labeled for single use.
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Manufacturer Narrative
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Upon further evaluation of one of the devices, it was discovered to be experiencing non-reportable issues.The count of events has been corrected to reflect this.
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Event Description
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This report summarizes 5 malfunction events, where it was reported the devices brakes cannot be engaged.There was no patient involvement.
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Search Alerts/Recalls
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