Catalog Number IAP-0701 |
Device Problems
No Device Output (1435); Failure to Read Input Signal (1581)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/09/2019 |
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 intra-aortic balloon pump (iabp) had no arterial pressure (ap) signal after connecting the ap cable.Another cable was used to troubleshoot and the same issue occurred.As a result, the pump was exchanged for another and the signal was clear.Therapy was continued without further complications to patient and case completed successfully.There was no report of patient complications or injury.
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Event Description
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It was reported that the intra-aortic balloon pump (iabp) had no arterial pressure (ap) signal after connecting the ap cable.Another cable was used to troubleshoot and the same issue occurred.As a result, the pump was exchanged for another and the signal was clear.Therapy was continued without further complications to patient and case completed successfully.There was no report of patient complications or injury.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp ap waveform missing is confirmed by a teleflex field service agent.A loosened cable connection between the fos and cpm boards was identified and retightened during service.A loosened cable connection between the fos and cpm board can cause a lack of communication between the boards, resulting in a failure of fos ap signal transmitting to the pump.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 reporting complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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