MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CAREEVENT

Model Number	866435
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Death
Event or Problem Description
The customer reported red alarms are not flowing to the careevent device/system.The device was in use on a patient.A patient death was reported.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Functional testing of the device was performed remotely.The device report of the test indicates the asystole event was sent to the nurse assigned to the room, but the escalated events to the charge phone device reported "undeliverable - failed".A third notification was sent to the charge nurse, which also failed.It was determined the phones used, belong to ascom and the charge nurse phone was broken.There was no malfunction of the philips device.The device remains at the customer site.

• Brand Name: CAREEVENT
• Common Device Name: CAREEVENT
• 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: 18272721
• Report Number: 1218950-2023-00904
• Device Sequence Number: 11764045
• Product Code: MSX
• UDI-Device Identifier: 00884838099128
• UDI-Public: 00884838099128
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866435
• Device Catalogue Number: 866435
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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 Sex: Unknown