MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Wireless Communication Problem (3283)

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

Event Date 01/21/2023

Event Type  malfunction  

Event Description

The customer reported that the patient information center ix system was down hospital wide.This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.The following functional tests were performed: the rse tested the connection to the surveillance from the server using hostname and ip address which was successful.The rse then tested the dns name and ip address, and they were successful.The cpu was then checked, and a spike was found around 11:55pm to 00:08am local time on the server.Results of functional testing indicate the host was communicating with the server, but the return time was in wait time and that took a longer time for some of the host to connect due to time wait.Based on the information available and the testing conducted, the cause of the reported problem was a cpu spike on the primary server.The reported problem was confirmed.Based on the information available and results of additional analysis further action has been initiated.A review of the risk management file was performed and determined that while philips devices provide mitigations related to the loss of centralized wireless monitoring (ie ¿no central mon¿ inop, visual and audible tones, local monitoring for mx40), a malfunction that leads to the loss of monitoring for numerous patients using mixed wireless devices may result in a delayed response to an individual patient requiring emergent care.The device was operational after the rse rebooted all the surveillance and the overview.After the reboot was performed all the surveillance started connecting, and once connected they were going into service mode, the rse reconnected to monitoring mode resolving the issue.The investigation concludes that no further action is required at this time.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16286186
• MDR Text Key: 308932194
• Report Number: 1218950-2023-00069
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1