Model Number R SERIES |
Device Problems
Failure to Capture (1081); Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2024 |
Event Type
malfunction
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device failed to capture the patient's heart rhythm and displayed a "hardware error 5" message.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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Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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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 observed during review of the device data logs.However, the device was put through extensive testing without duplicating the report.An internal inspection found no discrepancies.The pace/defib engine board was replaced as a precaution.The device was recertified and returned to the customer.The electrode pads used were not returned as part of this investigation.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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