Model Number MSERIES BI-PHASIC |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/02/2015 |
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 follow-up report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to treat an (b)(6) female patient, the device was intermittently unable to pace.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 corporation and the customer's report was not replicated or confirmed.The device was put through extensive testing, which included environmental and functional testing without duplicating the report.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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