Model Number R SERIES |
Device Problem
Unable to Obtain Readings (1516)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 03/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), the device displayed an "ecg fault" message.Complainant indicated that the clinician obtained another device to continue treating the patient.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing without duplicating the report.The analog board was replaced as a precaution.The customer declined repair and the device was sent back to the customer as unrepaired and labeled not for clinical use.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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