MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	4.2
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke to the customer biomedical engineer (biomed).The biomed reported that alarm sound was not audible after power outage at ward.The biomed told that they found the issue; the problem was that speaker was changed from external speaker to display speaker due to the power outage.They changed the external speaker to the main speaker in windows settings and the problem was solved.Based on the results of the analysis, it was determined that the product did not malfunction and the most likely cause of the reported problem was an external power outage.The issue was resolved by changing the settings to the external speaker as main speaker in windows.A review of the service history for this device shows no further reports have been submitted for this issue on 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.E1: reporting institution phone #: +358 6 2138162 reporter phone #: (b)(6).
Event or Problem Description
Philips received a complaint on a patient information center ix (pic ix) indicating that the ward reported that alarm sounds were not audible, even though alarms were triggered.The audio volume was checked and confirmed not to be muted.The volume level on the central station (pic ix) was set to level three.It was then adjusted to maximum, but no sound was heard from the speakers.Normally, a small test sound is audible when adjusting the volume, but no sound occurred.The speaker was replaced with a new one and the computer was restarted.Normally, a loud beep is heard during system startup, but no startup sound was heard.The speaker was also tested in a different port on the computer, with no improvement.A faint hissing noise can be heard from the speaker, but no functional audio output.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• 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 ; 70314632031
• MDR Report Key: 25149839
• Report Number: 9610816-2026-100918
• Device Sequence Number: 9351344
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: (01)00884838121782(10)4.2.4
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 4.2
• 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: 05/05/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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