MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE GUARDIANSOFTWARE

Model Number	E
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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 the general ward of the pulmonary unit.The guardian software was being used as the primary source of notification.The following was indicated 'there was no critical outcome for the patient, as the nurse was very alert and monitored the patient frequently rather than relying solely on the notifications from guardian.The patient therefore still received the proper care, although the nurse could have detected the deterioration earlier if.
Additional Manufacturer Narrative
A philips product support engineer (pse) evaluated the logs and determined that there was no issue with the device.If was found that the algorithm performs fine as expected i.E.It uses the live data to generate notifications.This is in line with the intended use of guardian.The customer noted they were using the guardian as a primary method of notification, which is off label.The device was confirmed to be operating per specifications, and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE GUARDIANSOFTWARE
• Common Device Name: INTELLIVUE GUARDIANSOFTWARE
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 23559788
• Report Number: 9610816-2025-001070
• Device Sequence Number: 15989712
• Product Code: DXJ
• UDI-Device Identifier: 00884838094253
• UDI-Public: (01)00884838094253(10)E.02.00
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K212208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E
• Device Catalogue Number: 866009
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown