Model Number R SERIES |
Device Problem
Self-Activation or Keying (1557)
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Patient Problem
No Information (3190)
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Event Date 09/09/2020 |
Event Type
Injury
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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 cardiovert a patient (age & gender unknown), the device self discharged a conscious patient.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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Zoll medical corporation evaluated the device and the customer's report was not replicated or confirmed.The device was put through extensive testing including full functional testing including defib stress testing without duplicating the report.Review of the device activity logs did not show any evidence to support the customer?s report that "the device gave an unexpected shock to a conscious patient".Therefore, our investigation for this reported malfunction was unsubstantiated.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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