Model Number X SERIES |
Device Problem
Loss of Power (1475)
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Patient Problems
Premature Labor (2465); No Information (3190)
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Event Type
malfunction
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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 monitor a patient (age & gender unknown) during transport, the device restarted/rebooted power one time.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.Device evaluation: the device was returned to zoll medical corporation; the customer's report was observed during review of the device's activity log.However, the reported problem could not be duplicated with the device.The monitor board was replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.Reports of this nature are typically not considered to meet our requirements for submission based on intended use of the device.
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Event Description
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Complainant alleged that during functional testing, the device restart/reboot itself.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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