Model Number 0998-00-0800-53 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that during unrelated service by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit's front end board pin was found to be broken.There was no patient involvement.
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Manufacturer Narrative
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Additional contact information: (name: (b)(6), email: (b)(6), occupation: biomed supervisor, contact: (b)(6).A getinge field service engineer (fse) replaced front end board.Also fse reformed unit checkout nvram section failed due to expiration on unit will send quote for executive processor replacement therefore - getinge does not recommend use.Unit return to customer.
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Event Description
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It was reported that during field action by a getinge field service engineer (gfse), the cardiosave intra-aortic balloon pump (iabp) unit's front end board pin was found to be broken.There was no patient involvement.
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Search Alerts/Recalls
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