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

Model Number	866435
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); Loss Of Pulse (2562)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips product support engineer (pse) spoke to the customer careevent manager (cem), and reviewed logs from the careevent.The investigation found that one alarm message ***xbrady 76 < 80 was delivered from bed 589a to clinical team members at 19:49:40.The first level nurse paging device (pivot 8742 smartphone) was not assigned to careevent assignments.At the same time, the buddy nurse received the philips alarm ***xbrady 76 < 80.The cem had tested the bedside monitor and philips information center being used with the paging system, and both were okay and in use.There was no product malfunction; this is considered a user issue, as the staff member's paging device was not assigned to careevent assignments.A philips product support engineer (pse) conducted an investigation of the philips software, and concluded that the system functioned as designed.The device remains in use at the customer site.No subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.Patient information requested not available at time of report.
Event or Problem Description
The customer reported that an alarm was not received on (b)(6) 2020 at 19:49:40 for a patient in room 589a.The output was on aruba access points (ap) with pivot 8742 smart phones.Error "no device assignment" listed in event transcript report.The patient had suffered a cardiac arrest.The staff entered the patient room for routine blood draw and found the patient had arrested with a flat line heart rate and not registering a pulse oxygenation.The patient was able to be resuscitated.

• 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: 9670774
• Report Number: 1218950-2020-00866
• Device Sequence Number: 2908116
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

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: 01/31/2020
• Initial Report FDA Received Date: 02/05/2020
• 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