VYAIRE MEDICAL INC. MULTI-LINK ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
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Model Number MULTI-LINK¿ ECG CARE CABLE, 12-LEAD, AHA, 3.6M / 12FT |
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 08/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).There was no photo, lot number, and no product was returned for evaluation; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.This complaint will be included in the ongoing complaint trending analysis.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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The customer reported that the ecg machine was alarming an asystole continuously even after the 2017006-001 multi-link¿ ecg care cable, 12-lead, aha, 3.6m / 12 ft cables are unplugged.This device is designed for monitoring and does not provide medication.Based on the available information, the customer did not report any patient or user harm as a result of the issue described.
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Search Alerts/Recalls
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