Model Number X SERIES |
Device Problems
Communication or Transmission Problem (2896); Unexpected Shutdown (4019)
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Patient Problem
No Information (3190)
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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 treat a patient (age & gender unknown), the device inappropriately shut down.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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This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also correcting information submitted on the initial medwatch report.Please reference device code.Evaluation results; the customer's report was observed during initial testing.Our evaluation found that the data logging was out of sync when the device was trying to transmit and/or store data.This is commonly seen when there are frequent power cycles of short duration when the log is full.Regular clearing of the device history logs should prevent such occurrences.As a result of the findings, the logs have been fully cleared to resolve the report.This report was inadvertently submitted and reports of this nature typically do not meet zoll's reportability requirements.Analysis of reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device had a case review transmission failure.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Search Alerts/Recalls
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