Model Number 15 |
Device Problem
Failure to Sense (1559)
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Patient Problem
Bradycardia (1751)
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Event Date 08/08/2021 |
Event Type
Death
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank. physio-control evaluated the customers device and was unable to duplicate the reported issue.Physio-control reviewed the device data and verified the reported issue.During evaluation physio-control determined the customers ecg cable produced a noisy ecg waveform and was recommended to be replaced as a precaution.Proper device operation was observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted physio-control to report that their device was unable to pace a patient.This issue is patient related.The customer indicated "caregivers were able to obtain a pulse but the patient expired later at the hospital.The device use may have contributed to the patients death as the patient was hemodynamically unstable at the time of pacing.
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Event Description
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The customer contacted physio-control to report that their device was unable to pace a patient.This issue is patient related.The customer indicated "caregivers were able to obtain a pulse but the patient expired later at the hospital.The device use may have contributed to the patients death as the patient was hemodynamically unstable at the time of pacing.
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Manufacturer Narrative
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Initial mfr 0003015876-2021-01706, section h11, stated physio was unable to duplicate the reported issue.Section h11 should state that physio was able to verify and duplicate the reported issue using the original cables, however no defect was found with the lp15 device in relation to the issue.
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Search Alerts/Recalls
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