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 03/24/2023

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

It was reported that the limits that are set on the control center do not alarm.The reason for this is that the mx40 telemetry device does not take over the set limits of the control center.The problem is that the control center indicates that the limits have been set.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

Manufacturer Narrative

The remote service engineer (rse) escalated the case to the business unit (bu).The complaint was escalated for technical investigation, the reported issue was confirmed to be due to a software design error within the pic ix software version.The issue will be resolved with a software patch.

Manufacturer Narrative

The following fields were corrected: d1brand name d2a common device name d4 model #, catalog #, serial # and udi # g4 510(k) h4 device manufacture date.

• 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: 16788217
• MDR Text Key: 313754071
• Report Number: 1218950-2023-00251
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211900
• 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,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: 03/24/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/10/2023; 01/25/2024
• Supplement Dates FDA Received: 06/07/2023; 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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