Model Number X SERIES |
Device Problem
Failure to Analyze Signal (1539)
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Patient Problem
Necrosis (1971)
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Event Date 05/26/2021 |
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 monitor a patient (age & gender unknown), the device was unable to analyze.Complainant indicated that the patient subsequently expired.
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Manufacturer Narrative
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The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
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Manufacturer Narrative
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The device was received at zoll medical corporation and the customer's report was unsubstantiated.Review of the device log shows evidence that the device successfully analyzed 4 times in response to analyze button presses.The first resulted in a shock advised, and the remaining three resulted in no shock advised.During the only shock advised prompt, energy was not delivered.The device passed all testing without duplicating the report.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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