Catalog Number IAP-0500 |
Device Problems
No Device Output (1435); Unable to Obtain Readings (1516)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2019-00437 and (b)(4) as the report is related to the same patient.
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Event Description
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It was reported the intra-aortic balloon pump (iabp) ap and ecg signal were not present while in use.The display led's were flashing and there were alarms but it was not recorded.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.The field service engineer (fse) serviced the iabp and could not replicate the problem, the iabp ran perfectly.
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Manufacturer Narrative
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Qn#: (b)(4).No iabp part or recorder strip was returned to teleflex chelmsford for investigation.The reported complaint of ap signal not present is not able to be confirmed.A teleflex field service agent serviced the pump and could not duplicate the reported complaint.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 revived risk.This will be monitored for any developing trends.Other remarks: see mdr# 3010532612-2019-00437 and (b)(4) as the report is related to the same patient.
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Event Description
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It was reported the intra-aortic balloon pump (iabp) ap and ecg signal were not present while in use.The display led's were flashing and there were alarms but it was not recorded.As a result, the pump was swapped out.There was no report of patient complications serious injury or death.The field service engineer (fse) serviced the iabp and could not replicate the problem, the iabp ran perfectly.
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Search Alerts/Recalls
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