MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	PATIENT INFORMATION CENTER IX
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer received remote clinical assistance by the philips remote clinical support engineer (rcse).The rcse talked to the customer clinical consultant (cc) who explained and confirmed, while testing the ecg and spo2t together with the mx40 monitor, after removing the ecg leads, the ecg leads off condition occurs.However the application did not switch to pulset alarm source as expected by the cc.The cc confirmed as well the pulse alarm were default 'on'.The pic ix current software version is c.02.07 and the mx40 software revision is b.02.The rcse explained to the customer cc that the new spo2t pulse alarm for the mx40 device is only available for software release later than software version b.07.Based on the information available and the testing conducted, the cause of the reported problem was due to user knowledge.The reported problem was confirmed.The device was confirmed to be working to its speciation.The reported issue is due to capabilities of the used software revision which represents user knowledge/issue.The investigation concludes that no further action is required at this time.
Event or Problem Description
It was reported that the patient information center ix (pic ix) pulset alarms are not available, when monitoring ecg and spo2t on the mx40 and a leads off condition occurs.The customer wants to know why this happens.The device was in use.There was no report of patient or user harm.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 23299209
• Report Number: 1218950-2025-000600
• Device Sequence Number: 17340152
• Product Code: MHX
• UDI-Device Identifier: 00884838086715
• UDI-Public: (01)00884838086715(10)C.02.07
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: PATIENT INFORMATION CENTER IX
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2019
• 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