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

Model Number MX40-1C4

Patient Problem Cardiac Arrest (1762)

Event Date 02/13/2024

Event Type  Death  

Event Description

Pt on philips mx40-1c4 telemetry monitor.Unclear if monitor was capturing from 23:59 - 02:22 on (b)(6) 2024.Pt found in full arrest and resuscitation unsuccessful.Unk at this time if it is user or device error contributed to the outcome.

• Brand Name: PHILIPS MEDICAL SYSTEMS
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC.
• MDR Report Key: 18948899
• MDR Text Key: 338230584
• Report Number: MW5153018
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: MX40-1C4
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White