INTELLIVUE MULTI-MEASUREMENT MODULE X3
Received Apr 21, 2025 · Event occurred Apr 16, 2025
Report 21872166 · MDR key 21872166
Device
Generic name
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Manufacturer
Philips Medizin Systeme Boeblingen GmbhModel number
INTELLIVUE X3Catalog number
867030
Product problems
- Device Alarm System
- Material Integrity Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
YOUNG PATIENT KEEPS REMOVING OXYGEN AND PULSE OXIMETERS. PATIENT REMOVED PULSE OXIMETER (OX), AND NO ALARM GENERATED TO NOTIFY CLINICIANS THAT PULSE OX HAD BEEN REMOVED. IN FURTHER REVIEWING, THE READING WAS NOT PICKED UP FOR ABOUT 30 MINUTES BEFORE IT WAS REALIZED. THIS FUNCTIONALITY IS WORKING AS INTENDED BY PHILIPS, WITH THE CYAN INOPERATIVE MESSAGE NOT PAGING OUT AS A HIGHER-LEVEL ALARM. HOWEVER THIS FUNCTIONALITY IS INADEQUATE FOR CLINICIAN NOTIFICATION AT THIS FACILITY, AND THE FACILITY IS REQUESTING ENHANCED FUNCTIONALITY TO INCLUDE CONFIGURABILITY OF THESE ALARMS UP TO A 'RED-LEVEL' ALARM THAT CAN APPROPRIATELY PAGE OUT AND NOTIFY CLINICIANS OUTSIDE THE PATIENT ROOM.