MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CAREEVENT REL A.0; CARDIAC MONITOR

Model Number	866435
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported an alarm problem, there is no call forwarding.The device was not in use on a patient.
Additional Manufacturer Narrative
H10: a philips remote service engineer (rse) spoke with the customer and confirmed the reported issue.The rse indicated that a meeting would be held with the facility information technology (it) department to discuss the issue.Good faith efforts were made to obtain additional information associated with this complaint evaluation, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.It could not be confirmed that the philips device had a malfunction.The cause is unknown.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: CAREEVENT REL A.0
• Common Device Name: CARDIAC MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11195271
• Report Number: 1218950-2021-00336
• Device Sequence Number: 11603081
• Product Code: MSX
• UDI-Device Identifier: 00884838081284
• UDI-Public: (01)00884838081284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 866435
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1