MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number	866389
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
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.Reporting institution phone #: (b)(6).Reporting phone #: (b)(6).
Event or Problem Description
It was reported the alarm limits for heart rate had been set to 155 bpm and there was no red alarm when heart rate went above this limit for over 5 minutes.The clinical audit logs were reviewed with the customer, revealing the limit was set to 155 with a delta of 20 bpm for a red alarm; therefore, a red alarm would be triggered at 175 bpm.It was confirmed a yellow alarm was generated visually and audibly; however, no red alarm occurred due to the configured alarm limits.It was indicated the impact to the patient was 'patient collapsed' but no further details were provided.
Additional Manufacturer Narrative
The philips clinical application specialist confirmed from the audit log at the control center that yellow alarms were triggered for the event, and that visual and audible alarms were triggered at the control center.The logs confirmed a user had changed the yellow alarm limit to 155bpm with a delta of 20bpm to enable a red alarm would be triggered at 175bpm.The yellow alert was consistent with the configuration, and the notification was delivered to supervisors.No malfunction was detected.A review of the device logs by the philips product support engineer confirmed that there are additional beds that show yellow alarms when the heart rate is above 155.The pse suggests that a user could have changed the upper limit setting for the yellow alarm, but not just for one bed, but for multiple beds.Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The reported problem was not confirmed.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 21632450
• Report Number: 9610816-2025-000223
• Device Sequence Number: 13080569
• Product Code: MHX
• UDI-Device Identifier: 00884838112070
• UDI-Public: (01)00884838112070(10)4.1.1.0
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 06/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866389
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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