Model Number N/A |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The stm replaced the ac power cord then completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.The full name of the event site was shortened due to field character limit; the full name is (b)(6).
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Event Description
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It was reported that during a service visit for a previously reported issue, a getinge service territory manager (stm) observed a bent ground pin on the power cord.There was no patient involved and no adverse event was reported.
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Manufacturer Narrative
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The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported issue were noted.The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).
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Event Description
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It was reported that during a service visit for a previously reported issue, a getinge service territory manager (stm) observed a bent ground pin on the power cord.There was no patient involved and no adverse event was reported.
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Search Alerts/Recalls
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