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

Model Number 866389

Device Problem Application Network Problem (2879)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the host screens went white and lost connection hospital wide.The device was in use at time of event, there was no adverse event reported.

Manufacturer Narrative

Philips received a complaint on the patient information center ix indicating that at 11:05 am on (b)(6) 2023, the entire system went down.It was reported that the host screens went white and lost connection, so the customer wanted root cause analysis (rca).The following functional tests were performed: a remote service engineer (rse) remoted onto the primary server, and all hosts were functional.The customer wanted to know why the host screens went white.The rse checked the log viewer and found some "software update" and "time" messages.The rse informed the customer that rca would require onsite technician.A field service engineer (fse) tried to contact the customer to arrange a date to go onsite but was unable to get a response from the customer it department.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.We are unable to confirm the final disposition of the device, because the customer did not respond to requests for additional information.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: 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: 18238909
• MDR Text Key: 329386773
• Report Number: 1218950-2023-00897
• 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: K183387
• 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,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: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2020
• 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