Model Number X SERIES |
Device Problems
Defibrillation/Stimulation Problem (1573); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 biomed testing, the device's defib output was out of specification and would not go into sync mode.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 corporation for evaluation.The customer's report of "defib output incorrect" the device was evaluated and determined the device performed to specification.The customer's report of "unable to sync" was observed during initial testing; however, after disassembling the device to determine root cause, the report was no longer seen.The ecg board was replaced as a pre-caution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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