Model Number X SERIES |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2019 |
Event Type
malfunction
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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 switches settings on it's own.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 device was returned to zoll medical (b)(4) service department.The device was put through extensive testing which included full functionality testing without duplicating the report.The report was observed during review of the device's history log.The monitor board was replaced as a precaution.The device was recertified and returned to the customer.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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