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

Model Number 866389

Device Problems Alarm Not Visible (1022); Power Problem (3010)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

The customer reported that alarms from the monitors were not displayed at the control center.The device was in use on patient at time of event, there was no adverse event reported.

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.E1: reporter institution phone number (b)(6).E1: reporter phone number (b)(6).

Manufacturer Narrative

Philips received a complaint on the patient information center ix, indicating that the alarms from the monitors were not displayed on the control panel.A good faith effort (gfe) was performed to further clarify the allegation, and it was provided that the issue was specifically related to the unexpected shutdown.The device was in use on patient at time of event, there was no adverse event reported.The remote service engineer (rse) spoke to the customer and found that there was a control center failure and restart.The rse determined that the control panel shut down unexpectedly during operation and explained that in most cases, this is a result of problems with the power supply.The rse was unable to find any entries about a hardware problem with the pc itself.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.The rse advised the customer to check the wiring of the power supply as well as the ups.It is unknown what caused the issue, as the customer did not call back for further assistance.

• 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: 18336139
• MDR Text Key: 330609990
• Report Number: 1218950-2023-00931
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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

• Date FDA Received: 12/15/2023
• 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: 01/05/2024
• Date Device Manufactured: 02/24/2017
• 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