Model Number MSERIES BI-PHASIC |
Device Problem
Failure to Select Signal (1582)
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Patient Problem
Premature Labor (2465)
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Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device was unable to select energy level.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 returned to zoll medical italy for evaluation.The reported malfunction has been attributed to high contact resistence within the front panel membrane.Analysis of similar reports from older devices has shown that the keys do respond; however, they need to be pushed harder to activate.Due to the fact that the device can still administer therapy, reports of this nature do not typically meet the criteria for reportability.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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