Model Number R SERIES |
Device Problem
Self-Activation or Keying (1557)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
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 cardiovert a male patient, (age unknown), the device self discharged when the energy up button was pressed.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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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b3.The device was returned to zoll medical corporation for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing without duplicating the report.An internal inspection of the device found no discrepancies.Review of the device log found the device was charged at 120j and discharged at 120j to the patient as a result of a shock button press.There was no energy up or down button press registered in the log after the charge button was pressed.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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