REUSABLE MULTIPHRAM ACC ECG CABLE 3-LEAD SHIELDED
Received Feb 7, 2025 · Event occurred Jan 14, 2025
Report 3008818980-2025-00002 · MDR key 21333497
Device
Generic name
Cable, Transducer And Electrode, Patient, (including Connector)
Manufacturer
Icu Medical, Inc.Catalog number
21-0461-51
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ECG LEAD WAS DEFECTIVE. THE MONITOR WAS NOT READING ECG OR WOULD READ INACCURATELY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.