Model Number IPN000320 |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).There is an investigation ongoing into this reported complaint.A supplement follow-up mdr report will be submitted with the investigation results upon completion of the investigation.
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Event Description
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It was reported that frequent drain failure alarms occurred during use on a patient.The condensation bottle was empty.Helium drive line tubing clear and dry.The staff tried manual purge, the pump worked for about 2 minutes and issued the alarm again.As a result, the pump was swapped out and sent to biomed.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 frequent drain failure alarms is not able to be confirmed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the 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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Event Description
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It was reported that frequent drain failure alarms occurred during use on a patient.The condensation bottle was empty.Helium drive line tubing clear and dry.The staff tried manual purge, the pump worked for about 2 minutes and issued the alarm again.As a result, the pump was swapped out and sent to biomed.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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