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

Model Number	4.5
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on a patient information center ix indicating that the heartrate measurement for a patient was inaccurate (20-30 bpm).An mx40 was being used for ecg monitoring and when the accuracy was doubted, it was switched for an mp5; however, the heartrate was still low.Biomed tested both monitors and found both to be accurate.The patient was placed on an ecg cart for analysis, and the heartrate was found to be approximately 80 bpm.The device was in use on a patient at time of event, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis was performed by remote clinical support personnel which included remote trouble shooting, walking through testing with simulator and review of settings, including star arrhythmia monitoring setup.The results of the analysis confirmed the device was working accurately; however, the qrs threshold was noted to be high (300uv) instead of low (150uv).Based on the results of the analysis, the product was confirmed to be operating per specifications, and the cause of the reported problem was related to incorrect qrs threshold setting.The customer was provided with the quick guide as well as the star arrhythmia monitoring guide.The issue was resolved by changing the qrs threshold from high (300 uv) to low (150uv).After correction, the ecg beats and rhythm measurement were working as expected.A review of the service history for this device shows the problem has not been reported again for this device.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received, the complaint file will be reopened for further investigation.

• 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: 50807601
• Report Number: 9610816-2026-101935
• Device Sequence Number: 21480261
• Product Code: MHX
• UDI-Device Identifier: 00884838127074
• UDI-Public: (01)00884838127074(10)4.5.1.0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/17/2026

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: 4.5
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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
• Patient Sex: Unknown