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

Model Number	866435
Health Effect - Clinical Code	Cardiopulmonary Arrest (1765)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A philips remote service engineer (rse) worked with the customer.The investigation found that there is tcp/com software on the rauland server and the philips careevent (paging) server.The rauland system underwent a microsoft update which included a restart.The customer it team failed to perform a required tcp/com software restart on the rauland server as part of the process resulting in a failure to communicate with care event.There was no product malfunction; this issue is due to a non-philips product.The issue was determined to be with the rauland nurse call.Information was provided to the customer to perform a tcp/com software restart on the rauland server.Amtek rauland was notified of this report and the notification is attached to this record.No further investigation or action is warranted at this time.
Event or Problem Description
The customer reported that a code blue was not paged to the nurses' phones.The device was in use.Patient details were not provided.

• 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: 10794638
• Report Number: 1218950-2020-06708
• Device Sequence Number: 19773070
• Product Code: MSX
• UDI-Device Identifier: 00884838081284
• UDI-Public: (01)00884838081284
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/22/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 866435
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening