MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC CAREEVENT

Model Number	866435
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/10/2022
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported the patient monitoring alerts red and yellow are not received on waveware snpp pager it is unknown if the device was in clinical use at the time the issue was discovered.A patient death occurred.
Additional Manufacturer Narrative
Complaint is still under investigation and philips is in the process of obtaining additional information for complaint completion.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
It was reported the patient monitoring alerts red and yellow are not received on waveware snpp pager, the device was in clinical use at the time the issue was discovered.A patient death occurred.The bedside monitor and piic were tested by a philips field service engineer (fse).The bedside monitor was working as expected and the data flow of the piic red and yellow alerts were confirmed.It was determined that the careevent software was not indicated to have contributed to the event.The cause of the reported problem was the failure of the customer owned pager transmitter, manufactured by waveware, which was found to be defective.The device remains at the customer site.
Event or Problem Description
It was reported the patient monitoring alerts red and yellow are not received on waveware snpp pager, the device was in clinical use at the time the issue was discovered.A patient death occurred.The bedside monitor and piic were tested by a philips field service engineer (fse).The bedside monitor was working as expected and the data flow of the piic red and yellow alerts were confirmed.It was determined that the careevent software was not indicated to have contributed to the event.The cause of the reported problem was the failure of the customer owned pager transmitter, manufactured by waveware, which was found to be defective.The device remains at the customer site.

• Brand Name: CAREEVENT
• Common Device Name: CAREEVENT
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15816047
• Report Number: 1218950-2022-01005
• Device Sequence Number: 14784545
• Product Code: MSX
• UDI-Device Identifier: 00884838099128
• UDI-Public: 00884838099128
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 866435
• Device Catalogue Number: 866435
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 11/10/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 01/11/2023; 02/07/2023
• Date Device Manufactured: 06/26/2020
• 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