MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE PATIENT MONITOR MX100

Model Number	INTELLIVUE MX100
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an oxygen desaturation occurred, but the monitor did not generate an alarm.It was indicated the user noted the change in patient's desaturation and the red alarm was generated belatedly.The patient's pulse rate dropped as well.The patient was ventilated with a bag-valve mask and no further resuscitation was required.The user indicated the patient's deteriorating condition could not be seen in the monitor trends and there was no technical alarm.A review of the clinical audit log revealed both the desaturation and pulse drop alarms were generated.The desaturation alarm delays and spo2 measurements occurred according to the monitor configuration.Based on this information, there does not appear to be a malfunction of the device that contributed to the reported event; however, use error in the form of alarm management and possible clinical workflow may have been factors.
Additional Manufacturer Narrative
Patient involvement was reported, the patient experienced a a drop in oxygen saturation.The patient was ventilated with a bag-valve mask and no further resuscitation was required.The customer indicated that there was a sharp drop in oxygen saturation, which was not alarmed in a timely manner.It was indicated that the patient's pulse rate dropped as well.The logs and information provided were reviewed by the rse.The logs provided indicated that the alarm delays occurred according to the configuration.This configuration can be adjusted as needed in the basic configuration or individually for each patient.The spo2 measurements were performed consistently, and no technical errors were reported.A philips product support engineer (pse) also reviewed the logs and provided the following analysis: already at 16:37/38 a yellow spo2 alarm was announced at the bedside and central (generiert = generated): at 17:25 the alarm was acknowledge (quittieren) at the bedside (beendet = stopped) at 17:50/51 again spo2 alarms were announced: also a red spo2 desaturation alarm was generated at 17:52 at the same time the alarm was again acknowledged.This time it was acknowledged from the central.Again a red alarm was issued at 17:55 at 17:56 the alarm was acknowledged from the bedside monitor and the alarms were again stopped (beendet = stopped): it further continued at v18:05 where yellow spo2 alarms were generated but silenced again from the central: new alarms generated at 18:07: and it was silenced at 18:31: so during the time in question 5:55 pm (=17:55) there have been several spo2 alarms which have been announced but were acknowledged sometimes from the central and sometimes from the bedside.No inop¿s were present at time of incident which indicates there was no sensor issue or a monitor malfunction.The device was confirmed to be functioning as configured.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporting institution phone # (b)(6).Reporter phone # (b)(6).

• Brand Name: INTELLIVUE PATIENT MONITOR MX100
• Common Device Name: INTELLIVUE PATIENT MONITOR MX100
• 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: 22782971
• Report Number: 9610816-2025-000727
• Device Sequence Number: 8145245
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: (01)00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: INTELLIVUE MX100
• Device Catalogue Number: 867033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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