IntelliVue GuardianSoftwareRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · IntelliVue GuardianSoftware is a software-only product. It is the core of the Guardian General Care Solution, which provides fully customizable workflow support for automated vital signs taking, early warning scoring, patient deteroration detection, caregiver notification and care escalation for medical/surgical care, ED waiting/triage and other general care areas. It also mediates the data flow between the devices and hospital systems. Guardian Software license options listed enable desired features and capabilities for specified number of patients, clients, selected measurement technologies as well as required connectivity to hospital systems. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838094253), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Alarm” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Alarm1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Defective Alarm; Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE GUARDIANSOFTWARE INDICATING AN ALERT WAS NOT GENERATED FOR AN OXYGEN DESATURATION. THE ISSUE OCCURRED FOLLOWING A PET SCAN THE PREVIOUS DAY, AFTER WHICH CLEAR CLINICAL DETERIORATION OCCURRED. THE PATIENT EXHIBITED INCREASINGLY FREQUENT AND SEVERE OXYGEN DESATURATIONS, WITH SATURATION LEVELS DROPPING INTO THE 70S, ACCOMPANIED BY CYANOSIS AND PALLOR. NURSING STAFF HAD BEEN INSTRUCTED TO MONITOR THE PATIENT HOURLY DUE TO THESE RISKS. THE PATIENT'S CONDITION HAD CONTINUED TO DECLINE THROUGHOUT THE EVENING, WITH SPO2 VALUES DROPPING AROUND 50%; HOWEVER, ONLY ONE ALERT OCCURRED AROUND 21:18. NO FURTHER ALERTS WERE GENERATED THROUGHOUT THE REMAINDER OF THE EVENING AND OVERNIGHT, DESPITE CRITICAL AND ABNORMAL VALUES. DURING THE NIGHT AT APPROXIMATELY 01:00, STAFF NOTICED SIGNS OF ACUTE DETERIORATION, BUT THE SYSTEM DID NOT GENERATE A NOTIFICATION. AT THE NURSING STATION, THE SPO2 VALUE WAS 74% AND BY THE TIME STAFF HAD REACHED THE PATIENT, SPO2 WAS 66%. THE PATIENT WAS CYANOTIC, PALE, AND HAD NOT CALLED FOR HELP. IT WAS INDICATED THE PATIENT WAS WEARING A WEARABLE VIQTOR DEVICE THAT COMMUNICATED WITH THE GUARDIAN SOFTWARE AND WAS LOCATED IN TH
Patient problems: Low Oxygen Saturation
MAUDE report 23559788 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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