MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CAREEVENT

Model Number	866435
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection found by the remote service engineer that there were no patient disconnection alarms.Instead, there would have been a low vm alarm.Results of functional testing indicate for the case of patient disconnection for the evita xl, as documented this could not be tested, we failed to generate the alarm on the device at the time of testing.It seems that this is possible now i think that doing a test session would be the best way to move forward on this problem.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was not confirmed.The device was operational after investigation was completed.The investigation could not duplicate the issue.Further testing will be conducted on the fse's next visit to try to replicate the vm alarm.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the careevent (866345 indicating that device sent a false signal (problem with the re-up).Patient involvement is unknown.There was no report of patient or user harm.

• 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: 17906586
• Report Number: 1218950-2023-00749
• Device Sequence Number: 20789130
• Product Code: MSX
• UDI-Device Identifier: 00884838081284
• UDI-Public: 00884838081284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 866435
• Device Catalogue Number: 866435
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2018
• 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
• Patient Sex: Unknown