Model Number X SERIES |
Device Problems
Failure to Power Up (1476); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/12/2021 |
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 patient (age & gender unknown), the device inappropriately shut down and would not power up.Complainant indicated that the clinician obtained another device to continue treating the patient.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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The customer's report was not replicated or confirmed.The device passed all testing including full functional testing without duplicating the report.Review of the log shows that each time the device was powered on it was not connected to ac power and when powered off, it was done so by pulling the battery from the device.The device was recertified and returned to the customer.The battery used was not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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