Model Number IPN001112 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/02/2021 |
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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There was no patient involvement.It was reported that during daily checks on the intra-aortic balloon pump (iabp), the user noticed that the ecg waveform during start-up was 'wonky' when there was no ecg connected.The iabp was also alarming 'fos out of range' and 'fos cal key missing or damaged'.For these reasons the user didn't used the iabp on patient and called to arrange a service visit, which was scheduled for monday 5th july.
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Event Description
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There was no patient involvement.It was reported that during daily checks on the intra-aortic balloon pump (iabp), the user noticed that the ecg waveform during start-up was 'wonky' when there was no ecg connected.The iabp was also alarming 'fos out of range' and 'fos cal key missing or damaged'.For these reasons the user didn't used the iabp on patient and called to arrange a service visit, which was scheduled for monday (b)(6).
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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 several alarms is not able to be confirmed.The product was not returned for investigation.According to the service report, the fos pcb and fos slider were replaced.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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Search Alerts/Recalls
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