Model Number E SERIES |
Device Problem
Electrical /Electronic Property Problem (1198)
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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 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 biomed testing the device's pacer output was out of specification.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 canada; the malfunction was not verified.The device was put through extensive testing without duplicating the malfunction.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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