Model Number X SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Necrosis (1971)
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Event Date 11/21/2020 |
Event Type
Death
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Manufacturer Narrative
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Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant indicated that the patient subsequently expired.
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Manufacturer Narrative
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Zoll medical corporation evaluated the device and the device performed to specification.The device was recertified and returned to the customer.Review of the device log indicated the device was in lead ii and lead iii for the first 15 minutes of the case.It was not until after the device went into rescue protocol that the device displayed ecg via pads.Once the lead view was changed to pads,the ecg signal was displayed for the remainder of the case.The device performed as designed.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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