Model Number R SERIES |
Device Problem
Failure to Capture (1081)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
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 pace a patient (age & gender unknown), the device failed to capture the patient's heart rhythm.Complainant indicated that the clinician obtained another device 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 device was returned to zoll medical corporation.The customer's report was not replicated or confirmed.The device passed functional pacing and shock testing without duplicating the report.The device was recertified and returned to the customer.The clinical data file was not available for review.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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