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Model Number IPN000320 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the staff stated the helium gauge showed more than half a tank, but they kept getting low helium tank pressure alarms.The staff stopped pumping and tried to restart and received purge failure alarms.It is not clarified if they powered down or just stopped pumping.As a result, the staff changed the tank, and now it showed the correct pressure.The pump will be sent to biomed when therapy is discontinued.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the staff stated the helium gauge showed more than half a tank, but they kept getting low helium tank pressure alarms.The staff stopped pumping and tried to restart and received purge failure alarms.It is not clarified if they powered down or just stopped pumping.As a result, the staff changed the tank, and now it showed the correct pressure.The pump will be sent to biomed when therapy is discontinued.There was no report of delay in therapy.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of "helium gauge is not accurate" is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the serial number/lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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