Model Number IPN000254 |
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 09/07/2021 |
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 the helium loss alarms occurred approximately every 30 minutes then to every "couple of minutes".It was noted that there was no blood in the tubing and the patient was actively moving and bending his leg.A leak test was performed and failed.As a result, md chose to continue the weaning process and the intra-aortic balloon (iab) was removed without issue or incident.There was no report of delay in therapy.There was no report of patient complication, serious injury or death.
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Manufacturer Narrative
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(b)(4).The product was not returned for investigation.The reported complaint of iab helium loss alarm 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 the helium loss alarms occurred approximately every 30 minutes then to every "couple of minutes".It was noted that there was no blood in the tubing and the patient was actively moving and bending his leg.A leak test was performed and failed.As a result, md chose to continue the weaning process and the intra-aortic balloon (iab) was removed without issue or incident.There was no report of delay in therapy.There was no report of patient complication, serious injury or death.
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Search Alerts/Recalls
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