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

Model Number 866389

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2024

Event Type  Death  

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.(b)(6).

Event Description

It was reported the alarm was not forwarded to the mobile devices and the patient passed away.The central station (pic ix) and the bedside monitor alerted correctly; however, it was alleged the alarms were not forwarded to the mobile devices.It was confirmed the staff indicated the nurse mobile devices did not alert.The asystole alarm was generated at 07:27 and confirmed at 07:53 per the clinical audit logs.After a review of the log data, the fse suspected two of the three mobile devices were turned off at the time of the event.Further investigation by the technician onsite two of the mobile devices were not connected to the correct network at the hospital so hospital it will be correcting this configuration on the mobile devices.It was thought by the fse that only one of the mobile devices was in use at the time of the event, but the careassist app was closed out, then reopened but no login was performed, which prevented alarms from being transmitted.Approximately 30 minutes later the app was logged in.Alarm forwarding was tested when all mobile devices were turned on with the app logged in and connected to the correct wifi, revealing no issues with alarm forwarding.It was confirmed there was no issue with the monitoring system as all alarms were generated appropriately.Based on this information, there was not any device malfunction which led to the reported death; however, use error occurred in that the user did not log into the careassist app and incorrect wifi connections may have been factors.

• 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: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 19177059
• MDR Text Key: 340999024
• Report Number: 1218950-2024-00297
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838121782
• UDI-Public: 00884838121782
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/04/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 110 KG