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

Model Number 866389

Device Problem Alarm Not Visible (1022)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

The customer reported that the system has no visual alarm.Patient involvement is unknown.There was no report of patient or user harm.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

Philips received a complaint on the patient information center, for an alarm issues.There were no patient injuries or events associated with this event.The following functional tests were performed: the remote service engineer (rse) instructed the biomed engineer to check various connections for workability.Based on the information available and the testing conducted, the cause of the reported problem was due to a faulty router in the network infrastructure.The reported problem was confirmed.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer biomed informed that they had lost connection to the careevent server.The issue occurred due to a faulty router in the network infrastructure.Once it department had corrected the issue on the router, everything was working as intended.The device was confirmed to be operating per specifications and no failure was identified.

• 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: 17984892
• MDR Text Key: 326262806
• Report Number: 1218950-2023-00793
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838093041
• UDI-Public: 00884838093041
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K183387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• 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: 10/02/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2022
• 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