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

Model Number	866389
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when you change an alarm limit, the change is not taken by the mx40.The biomedical engineer (biomed) was trying to generate red alarms to test the recording function, and none generated when the alarm limit was changed to 40 bpm.When the biomed showed staff how to turn off respiratory alarms or parameter, it did not turn off until the pic was rebooted.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Section e reporting institution phone # 01438 742012.A philips field service engineer (fse) went to the customer's site.The fse confirmed the customer's allegation.The reported issue was confirmed to be due to a software design error within the pic ix software version.The fse updated the software revision, tested alarm limits and confirmed all were operating as per manufacturers specification.The device was operational after repairs were completed and was returned to clinical use.

• 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: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17071637
• Report Number: 1218950-2023-00391
• Device Sequence Number: 20304935
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153702
• 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

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: 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: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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