Model Number R SERIES |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Information (3190)
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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 would not function and displayed multiple error messages.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 (b)(4)'s service department for evaluation and the customer's report was not duplicated under testing.Review of the device's history log does show occurrences of the customer report.As per the r series message and error guide ecg disabled message is persistant with the critical hardware failure on the ecg module and results in no ecg functionality.The analog board was 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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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown) the device displayed an "ecg disabled" message.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Search Alerts/Recalls
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