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

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	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A philips remote service engineer (rse) spoke with the reporting nurse.The nurse advised the rse that the pic ix (surv (vamch5ss1)) was just moved from a different floor by the biomed and now they are unable to hear the alarms from the external speaker.The rse recommended checking to see if the external speaker was connected and tested properly.The nurse was unable to check the connections at this time but will engage biomed and have them call back if needed.The nurse reported that the biomed would resolve the issue and call back if needed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Reporter phone # (b)(6).
Event or Problem Description
It was reported that the nurses are unable to hear the alarms on the pic ix when they go off.The device was in use on a patient at the time of the event.There was no adverse event reported.

• 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: 22991258
• Report Number: 9610816-2025-000819
• Device Sequence Number: 8806442
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: (01)00884838121782(10)4.2.1
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/08/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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
• Patient Sex: Unknown