MAUDE Adverse Event Report: Philips Medizin Systeme Böblingen GmbH Patient Information Center iX; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Model Number	Patient Information Center iX
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580)
Date of Event	07/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that a patient was found desaturating by staff who happened to walk by the room, which required resuscitation and transfer to a higher level of care.During the user's review of the alarm history, they identified several alarms around 1634 indicating "tele battery low," "no spo2," and "tele battery empty." based on those alarms, it was initially assumed the spo2 waveform had been lost, as it was indicated that the monitor technician did not receive an alert.However, after the user reviewed the waveform data, it appeared the spo2 waveform remained visible and had not been lost.When the user revisited the alarm history, they noted multiple "reminder" alarms, but they were not sure what those indicated.When the user reviewed the waveform trends, they observed the patient's oxygen saturation had been at 85% or below beginning around 1730, yet those desaturation events did not appear to be reflected in the alarm history.The customer requested assistance with interpreting the audit log and education on alarm/alarm reminder behavior.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

• Brand Name: Patient Information Center iX
• Common Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
• 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 ; +49(703)14632031
• MDR Report Key: 50406398
• Report Number: 9610816-2026-101723
• Device Sequence Number: 16091960
• Product Code: MHX
• UDI-Device Identifier: 00884838122772
• UDI-Public: (01)00884838122772(10)4.3.5.0
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K211900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: Patient Information Center iX
• Device Catalogue Number: 866389
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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: Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female