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Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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At the conclusion of the investigation, it was determined that the cause of the incorrect findings was due to the certified cardiographic technician cct misclassifying the arrhythmia.A corrected report was submitted to the account and the cct was retrained as a result.The report provided does not provide diagnosis; rather it provides preliminary findings from which the clinician may make a diagnosis based on clinical judgement and patient clinical history.
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Event Description
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An ecg result was provided to the physician that was incorrect; as a result, the patient was treated based on the incorrect finding.No patient harm was reported as a result of the unnecessary treatment.
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Search Alerts/Recalls
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