MULTI-LINK¿ ADAPTER
Received Jun 16, 2023 · Event occurred Apr 30, 2023
Report 3010838917-2023-00065 · MDR key 17145063
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Vyaire Medical OyModel number
TELE ADAPTER X2, 5/6-LEAD FOR APEXPRO FHCatalog number
2090101-110
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
Additional Manufacturer Narrative
H11:AFTER FURTHER REVIEW OF THIS COMPLAINT, VYAIRE MEDICAL FOUND OUT THAT THIS COMPLAINT ONLY HAD AN ACCESSORY DEFECT AND NO PATIENT WAS HARMED. THEREFORE, THIS IS DEEMED AS A NON REPORTABLE COMPLAINT TO VYAIRE MEDICAL.PLEASE DISREGARD AND VOID VYAIRE REFERENCE NUMBER:(B)(4) UNDER MFR REPORT NUMBER: 3010838917-2023-00065.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE TELEMETRY BOX DOES NOT READ PROPERLY ON PATIENTS.THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Additional Manufacturer Narrative
H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.