MULTI-LINK¿ ADAPTER
Received Jun 16, 2023 · Event occurred May 1, 2023
Report 3010838917-2023-00064 · MDR key 17144838
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
- Device Alarm System
- Device Alarm System
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 IS ONLY 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.
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.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS NO TELEMETRY ALERT ON THE PATIENT MONITOR. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.