Model Number R SERIES |
Device Problems
No Display/Image (1183); Unable to Obtain Readings (1516)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Additional procode: mkj.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 during a routine shift check by a clinician, the device displayed an "ecg disabled" message and the display blanked out.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was evaluated by zoll medical corporation.The reported fault of display blanks out was not duplicated or confirmed.The device was subjected to extensive troubleshooting which included full functionality testing without duplicating the reported malfunction.The reported malfunction of ecg disabled was not duplicated under testing.However review of device's history logs does show occurrences of reported error messages.The analog 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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