ARROW INTERNATIONAL LLC AC3 OPTIMUS IABP NA/EMEA; System, balloon, intra-aortic and control
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Model Number IPN917285 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2021 |
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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The report states that "the iabp system restarts automatically.Origin of failure unknown, the system works normal after restarting a few times".Additional information states that the event occurred prior to use on patient with no patient involvement.Associated mdrs; 3010532612-2022-00429, 3010532612-2022-00416, and 3010532612-2022-00419.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Additionally no recorder strip was returned for investigation.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "the iabp system restarts automatically.Origin of failure unknown, the system works normal after restarting a few times".Additional information states that the event occurred prior to use on patient with no patient involvement.Associated mdrs; 3010532612-2022-00429, 3010532612-2022-00416, and 3010532612-2022-00419.
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Search Alerts/Recalls
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