LNTELLIVUE PHILIPS PATIENT MONITOR 6000 SERIES
Received Apr 10, 2025 · Event occurred Mar 6, 2025
Report MW5168782 · MDR key 21814024
Device
Generic name
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
867313Product problems
- Fail-Safe Problem
- Wrong Label
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AN INCORRECT LASER MARKING WAS DISCOVERED ON PHILIPS INTELLIVUE 6000 SERIES PATIENT MONITORS. THE BACK PANEL DISPLAYS A SYMBOL FOR A 12-LEAD ECG, EVEN THOUGH THE PATIENT MONITORS ONLY SUPPORT A 6-LEAD ECG. THIS COULD LEAD TO INCORRECT TREATMENT OR DELAYS, AS USERS COULD MISTAKENLY ASSUME THEY CAN PERFORM A 12-LEAD ECG. THE CORRESPONDING "FIELD SAFETY NOTICE" FROM PHILIPS, WITH REFERENCE NUMBER 2025-CC-HPM-003. PHILIPS ALSO REFERS TO "FCO86202041". THANKS, (B)(6). REF REPORTS: MW5168781, MW5168783.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 5/12/2025 FOR REPORT MW5168782 TO UPDATE REPORTER'S NAME.