Model Number X SERIES |
Device Problems
No Display/Image (1183); Reset Problem (3019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2021 |
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 monitor a male patient (age unknown), the device powered on without display.Complainant indicated that there was no 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 and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).Evaluation: the device was returned to zoll medical corporation.The customer's report was duplicated and the monitor board was replaced to remedy 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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Event Description
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Complainant alleged that while attempting to monitor a male patient (age unknown), the device restart/reboot itself multiple times.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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Search Alerts/Recalls
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