Model Number X SERIES |
Device Problem
Inaccurate Synchronization (1609)
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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 while attempting to treat a male patient (age unknown), the device failed the sync test.Complainant indicated that there was no 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 for evaluation.The customer's report was not replicated or confirmed.The device was put through extensive testing including synced cardioverison test, bench handling and keypad testing without duplicating the report.An inspection of the device found no discrepancies.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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