Model Number X SERIES |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to monitor a patient (age & gender unknown), the device displayed a "ecg disabled" message.Complainant indicated that the clinician obtained another device to continue monitoring 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 corporation for evaluation and the data log was reviewed.Review of the data file confirmed the customer report.The device was evaluated through extensive functional testing and the reported malfunction could not be duplicated.Visual inspection identified foreign substance on the defib receptacle contact pins, but we were unable to firmly establish a relationship to the report.The defib receptacle and multifunction cable were replaced as a precaution.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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