Model Number AED PLUS |
Device Problem
Self-Activation or Keying (1557)
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Patient Problem
Necrosis (1971)
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Event Type
Death
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Manufacturer Narrative
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Zoll medical corporation has not received the device 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 treat a patient (age & gender unknown), the device self discharged without the user pressing the shock button.Complainant indicated that the patient subsequently expired.
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Manufacturer Narrative
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Zoll medical (b)(4) evaluated the device and the device performed to specification.The customer's report was not replicated or confirmed.The device is a fully automatic device and does not have a shock button.The device is designed to alert the user that a shock is being delivered, then automatically discharges with no operator interaction.Review of the device log shows that fourth analysis recognized a shockable rhythm and therefore delivered a shock.The device passed full functional testing including analyze testing without duplicating 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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Search Alerts/Recalls
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