Model Number 8011-0501-01 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
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 while attempting to defibrillate a patient (age & gender unknown), the associated defibrillator failed to discharge using these attached internal handles.Complainant indicated that the clinician obtained another set of internal handles to continue treating the patient.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 internal handles were returned to a zoll approved service provider for evaluation.The customer's report was not replicated or confirmed.The internal handles were applied to a test device and were put through extensive testing including the ohms measurement test and the discharge test without duplicating the report.A replacement set of internal handles were shipped 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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