MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFO CENTER IX

Model Number	866023
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that there were no monitoring systems in the whole hospital; everything was down.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.
Additional Manufacturer Narrative
A philips remote service engineer (rse) confirmed prior to answering the call that the biomed already fixed the issue.The customer restarted the primary server and all the hosts connected into the monitoring mode.The customer biomedical engineer (biomed) reported the event tracker dialog box was populated on screen and they had to answer questions, which means the server had shutdown.The biomed will investigate the uninterruptable power supply (ups).The system was fully operational at time of the call.Based on the information available and the testing conducted, the cause of the reported problem was the server shutting down.The cause of the server shutting down was not determined.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE INFO CENTER IX
• Common Device Name: INTELLIVUE INFO 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: 16974820
• Report Number: 1218950-2023-00338
• Device Sequence Number: 20443735
• Product Code: MHX
• UDI-Device Identifier: 00884838029620
• UDI-Public: 00884838029620
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102495
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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: 866023
• Device Catalogue Number: 866023
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2015
• 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