Model Number 20 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.The customer, a biomedical engineer advised that they concluded the defibrillation electrodes were bad.The device or defibrillation electrodes were not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
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Event Description
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The customer contacted physio-control to report that during a patient event their device prompted, "connect electrodes".The customer advised this occurred when attempting to shock a patient during a cardioversion procedure.In this state defibrillation therapy would not be available to a patient if needed.The customer advised that the defibrillation electrodes were replaced and the procedure was completed.There was no adverse patient outcome reported.
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Manufacturer Narrative
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Section h10 of the initial medwatch (mfr report # 0003015876-2021-01298) report indicates: physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.The customer, a biomedical engineer advised that they concluded the defibrillation electrodes were bad.The device or defibrillation electrodes were not returned to physio-control for evaluation.The root cause of the reported issue could not be determined.Section h10 of the initial medwatch (mfr report # 0003015876-2021-01298) report should indicate: physio-control contacted the customer to request additional information on the patient.The customer informed physio-control that no further patient information is available.Patient fields in which information is not provided were intentionally left blank.The device was not returned for evaluation.The customer changed the electrodes and confirmed normal function.The root cause was determined to be the electrodes (lot #033933).The electrodes were not returned to physio-control for further review.Therefore, further cause of the reported issue cannot be fully determined.The device remains in service with the customer and is functioning normally.
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Event Description
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The customer contacted physio-control to report that during a patient event their device prompted, "connect electrodes".The customer advised this occurred when attempting to shock a patient during a cardioversion procedure.In this state defibrillation therapy would not be available to a patient if needed.The customer advised that the defibrillation electrodes were replaced and the procedure was completed.There was no adverse patient outcome reported.
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Search Alerts/Recalls
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