Model Number 799-AEV1-00-01 |
Device Problems
Failure of Device to Self-Test (2937); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2021 |
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 treat a (b)(6) year-old male patient, the device displayed an unknown "self check failure" message.Complainant indicated that the clinician bag ventilated 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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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Please reference section b5 and h6 (device problem code).Evaluation: the device was returned to zoll medical corporation.The customer's report was observed during review of the device data logs.However, the device passed full functional testing including stress testing without duplicating the report.The smart pneumatic module board was replaced as a precaution.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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Event Description
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Complainant alleged that while attempting to treat a 39-year-old male patient, the device displayed an "airway pressure sensing failure - 1052" message.Complainant indicated that the clinician bag ventilated 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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Search Alerts/Recalls
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