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

Model Number 866023

Device Problem Application Network Problem (2879)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315696725
• Report Number: 1218950-2023-00338
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838029620
• UDI-Public: 00884838029620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 866023
• Device Catalogue Number: 866023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1