Model Number IPN917285 |
Device Problem
Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).
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Event Description
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It was reported that "a patient has been on the iabp for 2 days and it had been working well.They had the alarm message that there was a low helium tank.They changed out the tank and they still had the message and the helium gauge said zero.They changed out the tank for another helium tank and had the same issue.They then changed out the pump for a second pump.This pump is working well.Patient is stable and being supported".No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).The reported complaint of "pump had helium leak and purge failure alarms" is not able to be confirmed.No part was returned to teleflex chelmsford for investigation.The field service agent serviced the pump and could not replicate the alarm; however, the helium o-ring was found missing.The field service agent installed a new o-ring and the pump passed functional checkout.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "a patient has been on the iabp for 2 days and it had been working well.They had the alarm message that there was a low helium tank.They changed out the tank and they still had the message and the helium gauge said zero.They changed out the tank for another helium tank and had the same issue.They then changed out the pump for a second pump.This pump is working well.Patient is stable and being supported".No patient harm or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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