Model Number R SERIES |
Device Problem
Mechanics Altered (2984)
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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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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 functional testing, the device powered up in the incorrect mode.Complainant did not indicate that there was any patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation; the malfunction was duplicated and attributed to a faulty integrated circuit on the digital board.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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