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

Model Number 866023

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 08/28/2022

Event Type  malfunction  

Event Description

The customer reported that the central station was frozen.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

The philips remote service engineer (rse) was unable to confirm the event.There is no additional information in the file and the rse has not responded to additional information requests.This is considered a reported malfunction.The cause of the event is unknown.It is unknown if the issue was resolved.The device remained on site.

Manufacturer Narrative

This supplemental report is submitted with reference to manufacturer's report number 1218950-2022-00889.Additional information received regarding problem resolution.A remote service engineer (rse) spoke with the customer.The rse determined the issue was associated with the hospital it team making changes to the isp servers, in particular changes to the password complexity requirements of the local user needed to the isp services.Therefore, the ¿obtv internal¿ user is unable to start the services.The engineer determined that this could be resolved by it removing or excluding this user from their password policy.Once the system was back up and running the customer was advised that it is critical that the users check current patient bed status so that data is not sent incorrectly and that once the password policy expires, the system will go down again so they will need to organize a long term solution for this issue with their it team.The reported issue was resolved by the it team changing the password policy.There was no malfunction of the suspected device.No further investigation or action is warranted at this time.

• 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: 15595403
• MDR Text Key: 302526826
• Report Number: 1218950-2022-00889
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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: 08/28/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 08/28/2022
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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