Model Number 0620040600 |
Device Problems
No Pressure (2994); Output Problem (3005)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was loss of insufflation during procedure.
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Event Description
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It was reported that there was loss of insufflation during procedure.
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Manufacturer Narrative
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Alleged failure: cib chris, rep.Pm and turned off during case.(b)(4).The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be the extensive age of the unit and/or the 10 year period without calibration or preventative maintenance.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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