Model Number X SERIES |
Device Problem
Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
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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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Manufacturer Narrative
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The device was evaluated by a zoll representative at the customer site.The customer's report was observed by the zoll representative.It was determined that the user connected to stat pads instead of the self-test port.While performing a 30j self-test, the user would need to use the shorting plug to successfully complete a 30j self-test.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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