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

Model Number	866389
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional Manufacturer Narrative
A philips clinical specialist reviewed the logs & information provided.After checking the configuration files, the red alarms are visually and audibly latched which means that the user must acknowledge the alarm before it will end.The asystole alarm generated at 07:27:03 and was not acknowledged until 7:53:02 from bedside 34850.Vtachy alarm was generated at 07:57:37 and this alarm was acknowledged at 8:15:57 from the pic ix.Per the case notes, the alarms weren¿t forwarded to careassist mobile devices due to the devices not being logged in.The investigation by the technician onsite indicated two of the mobile devices were not connected to the correct network at the hospital so the 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.The cause of the reported problem was use error.The reported problem was confirmed.It was determined that the pic ix was working as designed and as configured.E1 reporting institution phone#: (b)(6).

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: 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
• Report Number: 1218950-2024-00297
• Device Sequence Number: 6500581
• Product Code: MHX
• UDI-Device Identifier: 00884838112070
• UDI-Public: (01)00884838112070
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 07/13/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 110 KG