Model Number X SERIES |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
Tachycardia (2095)
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Event Date 08/27/2023 |
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 cardiovert a patient (age & gender unknown), the device prompted a "cable fault" message.Complainant indicated that the clinician obtained another device to continue treating the 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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The device was returned to zoll medical canada for evaluation.The customer's report was observed during review of the device data logs.However, the device was put through extensive testing including bench handling and ecg stress testing without duplicating the report.The multifunction cable and multifunction receptacle were replaced as a precaution.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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