Model Number N/A |
Device Problem
Defective Device (2588)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted if subsequent information is provided.The initial reporter named, is a getinge designee who has different contact details from that of the event site.Please refer to the following phone number as contact information for the initial reporter: (b)(6).
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Event Description
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It was reported that a getinge designee attempted to perform a field action on the cs300 intra-aortic balloon pump (iabp), but was unable to perform the field action due to the iabp being non-operational with a possible bimba issue.The designee was also told by the customer that all repairs are done in house by their biomedical engineer.There was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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A getting field service engineer (fse) reported that the customer's ge biomed was already aware of this issue and was repairing it.The ge biomed did not call this repair in and would like to complete his repair of this iabp.The fse gave him some troubleshooting help and have left this to him to complete the repair after he orders the necessary parts.The unit does not perform the autofill calibration because the bimba purge fails and the autofill calibration is aborted.A supplemental report will be submitted if new information is provided.
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Event Description
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It was reported that a getinge designee attempted to perform a field action on the cs300 intra-aortic balloon pump (iabp), but was unable to perform the field action due to the iabp being non-operational with a possible bimba issue.The designee was also told by the customer that all repairs are done in house by their biomedical engineer.There was no patient involvement, and no adverse event was reported.
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Manufacturer Narrative
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The customer's ge biomed later reported that the repairs were completed and the iabp was cleared for clinical use.
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Event Description
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It was reported that a getinge designee attempted to perform a field action on the cs300 intra-aortic balloon pump (iabp), but was unable to perform the field action due to the iabp being non-operational with a possible bimba issue.The designee was also told by the customer that all repairs are done in house by their biomedical engineer.There was no patient involvement, and no adverse event was reported.
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Search Alerts/Recalls
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