Model Number X SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Death (1802)
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Event Date 11/01/2019 |
Event Type
Death
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Manufacturer Narrative
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Zoll medical corporation has not received the device 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 treat a patient (age & gender unknown) the device was unable to obtain an ecg signal via electrode pads.Complainant indicated that the patient subsequently expired; however, it was not a result of the reported malfunction.
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Manufacturer Narrative
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The customer was contacted for return of the suspect product.The customer has responded and indicated the product is at another location, and they're waiting to retrieve the device.
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Manufacturer Narrative
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The device was returned to zoll medical (b)(4) for evaluation.Zoll medical corporation evaluated the device, and the customer's report was not replicated or confirmed.The device was put through extensive testing which included front panel button testing, 30 joule tests with the customer's multifunction cable and cpr adapter without duplicating any malfunction.The device was recertified and returned to the customer.No trend is associated with reports of this type.Review of the device logs did not find evidence to support the reported event.The pads that were used during the event were not returned for evaluation.
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Search Alerts/Recalls
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