Model Number X SERIES |
Device Problems
Invalid Sensing (2293); Communication or Transmission Problem (2896)
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Patient Problem
Death (1802)
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Event Date 11/02/2013 |
Event Type
Death
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a follow-up report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to defibrillate a (b)(6) old female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that within tro minutes device showed rhythm and the clinician shocked the patient 5 times.Complainant indicated that the patient subsequently expired.
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Manufacturer Narrative
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This follow up medwatch report is reporting the evaluation of the device.This follow up medwatch report is also correcting information submitted on the initial medwatch report.Zoll medical corporation evaluated the device and the device performed to specification.Review of the device activity logs does show occurrence of the reported malfunction; however this does not indicate a device malfunction.It was determined that the user was not in pads view with no ecg cable attached to the patient.The activity log confirms when all defibrillation related criteria was met, the device was capable of delivering therapy.It is noteworthy to mention the electrode pads used at the time of the reported malfunction were not returned to zoll for evaluation.This claim has been closed as device meets specification.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Event Description
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Complainant alleged that while attempting to defibrillate a (b)(6) year old female patient, the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that within two minutes device showed rhythm and the clinician shocked the patient 5 times.Complainant indicated that the patient subsequently expired.
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Search Alerts/Recalls
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