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Catalog Number IAP-0500J |
Device Problem
Low Battery (2584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2018 |
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 after catheter insertion the user powered on the intra-aortic balloon pump (iabp) and switched from ac to battery but, suddenly the display blacked out and the iabp system powered downed, (the iabp stopped working).The iabp was replaced by a backup device in the hospital, and the therapy was continued without problem.There was no reported of death, serious injury or complications to the patient.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint of "the pump shut off on battery power" is not confirmed.The returned device passed both visual and functional test specifications.The root cause of the complaint is undetermined.Per operator's manual "the battery should be maintained at full charge whenever possible.Arrow international recommends that the autocat2 series iabp be kept plugged into a proper ac receptacle whenever possible including time when the unit is in storage or not in use.The power indicator will illuminate when ac power is present.The batteries should not be stored in a discharged state." no further action required.
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Event Description
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It was reported that after catheter insertion the user powered on the intra-aortic balloon pump (iabp) and switched from ac to battery but, suddenly the display blacked out and the iabp system powered downed, (the iabp stopped working).The iabp was replaced by a backup device in the hospital, and the therapy was continued without problem.There was no reported of death, serious injury or complications to the patient.
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Search Alerts/Recalls
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