ECG CABLES AND LEADSETS
Received Dec 24, 2025 · Event occurred Nov 26, 2025
Report 9610816-2025-001289 · MDR key 23887490
Device
Generic name
Electrocardiographic Lead Set, Reusable
Manufacturer
Philips Medizin Systeme Böblingen GmbhModel number
10 LEAD ECG TRUNK, AAMI/IECCatalog number
989803144791
Lot number
5A
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4 UNIQUE DEVICE IDENTIFIER (UDI): THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016; THEREFORE, NO UDI IS REQUIRED. THE UNIT WAS EVALUATED AND IT WAS IDENTIFIED THE 12-LEAD TRUNK CABLE WAS DAMAGED. THE CABLE WAS REMOVED FROM SERVICE. THE INTELLIVUE X2 WAS TESTED WITH A KNOWN GOOD CABLE 12 LEAD ECG CABLE FROM THE EMERGENCY DEPARTMENT. TESTED THE ECG AT 60 AND 120 BPM, AND EVERYTHING WAS READING CORRECTED. SIMULATED RESPIRATORY AND MUSCULAR ARTIFACTS AND EVERYTHING WAS SHOWING UP AS IT SHOULD. BASED ON THE RESULTS OF THE ANALYSIS, THE CAUSE OF THE REPORTED PROBLEM WAS A DAMAGED 12-LEAD TRUNK CABLE. THE DEPARTMENT REPLACED THE CABLE. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED THE 12-LEAD ECG WAS NOT READING CORRECTLY AS THERE AS A BIG DIFFERENCE BETWEEN THE ECG OBTAINED BY THE MONITOR AND ONE TAKEN BY THE PORTABLE EKG MACHINE. IT WAS DETERMINED THE 12-LEAD TRUNK CABLE WAS DAMAGED SO IT WAS REMOVED FROM SERVICE. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITH THIS COMPLAINT.