MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS CSCN CARDIAC MONITOR; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number MX40

Device Problems No Display/Image (1183); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2022

Event Type  malfunction  

Event Description

Central monitor screens went out displaying "no data tele" and were unable to connect to a server.Rebooted and screens returned to normal for several minutes and then went out again and required rebooting.Monitor did not return with reboot.Philips monitor notified.Fda safety report id# (b)(4).

• Brand Name: PHILIPS CSCN CARDIAC MONITOR
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC
• MDR Report Key: 14776158
• MDR Text Key: 294600826
• Report Number: MW5110418
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2022

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 Operator: Health Professional
• Device Model Number: MX40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic