Model Number 0620040610 |
Device Problems
Output Problem (3005); Pressure Problem (3012)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
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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Manufacturer Narrative
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Alleged failure: eib, ana, onsite, keep turning off on their own and will also not hold pressure/flow sjc0013940.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be an issue with the accessories used with the unit during the event and/or the unit being past due for calibration as it did not pass the flow rate test.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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Event Description
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It was reported that there was loss of insufflation during procedure.
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Search Alerts/Recalls
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