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	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the patient information center ix indicating that the patient heart rate is going over the stat limit it will not alarm.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) remoted into prs and evaluated the icu, tele, ed, and 2 west pic configurations after the upgrade.The device was in use for patient monitoring, monitoring was not interrupted, there was no patient harm, and no device failure occurred.The rse compared the current settings with the pre-upgrade configurations and confirmed that the pic upgrade did not change the relevant alarm settings.The 2 west latching was set to red alarms only, the heart-rate alarm behavior was set to short, and the qrs detection threshold was set to 300 uv; these settings could account for missed yellow alarm sounds, low-heart-rate alarms, and false asystole alarms.The rse explained the alarm latching and heart-rate behaviors to biomed and the charge nurse, demonstrated how to change the visual and audible latching settings on the mx750 bedside monitor, and advised that any changes would need to be applied to the icu bedside monitors.Retrospective review settings were aligned across the icu and 2 west pic systems, classic calipers were added to the applicable icu and 2 west hosts, and the rse explained that the new caliper feature automatically populates measurements that must be reviewed and adjusted by nursing staff before saving.Configuration files, alarm setting definitions, qrs threshold information, latching information, yellow heart-rate behavior information, and caliper screenshots were sent to biomed, and the clinical team was left to decide whether to modify the alarm settings.Biomed and the charge nurse confirmed they understood that the pic upgrade had not changed the alarm settings, understood the available configuration changes, and verified the classic calipers option.No further follow-up was requested; the system met specifications and was returned to use.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: 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: 50900338
• Report Number: 9610816-2026-102017
• Device Sequence Number: 5853180
• Product Code: MHX
• UDI-Device Identifier: 00884838132320
• UDI-Public: (01)00884838132320(10)4.8.2.0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2026
• 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
• Patient Sex: Unknown