CABLE, ECG MULTI-LINK 3/5-LEAD AHA
Received Oct 19, 2023 · Event occurred Aug 29, 2023
Report 3010838917-2023-00091 · MDR key 17970954
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Vyaire Medical OyModel number
CABLE, ECG MULTI-LINK 3/5-LEAD AHACatalog number
2017003-001
Lot number
NOT PROVIDED
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2017003-001 CABLE, ECG MULTI-LINK 3/5-LEAD AHA STOPPED PICKING UP CORRECTLY, HEART RATE WAS READING INCORRECTLY. THE INFANT THEN CODED BUT THERE WAS NO HARM AND NO DELAY OF TREATMENT.
Additional Manufacturer Narrative
H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.