MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40; CARDIAC MONITOR

Model Number MX40

Device Problem Telemetry Discrepancy (1629)

Patient Problem Cardiac Arrest (1762)

Event Date 01/01/2024

Event Type  Death  

Event Description

On (b)(6) 2024 at 0811, a (b)(6) male admitted to (b)(6) medical center (b)(6) for sepsis secondary to multifocal pneumonia, pulmonary edema, and respiratory failure.Patient placed on telemetry via lntellivue mx40 cardiac monitor.At 1303.Telemetry signal lost without low battery warning or alert.At 1344, patient found in cardiac arrest.

• Brand Name: INTELLIVUE MX40
• Type of Device: CARDIAC MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; andover MA
• MDR Report Key: 19015054
• MDR Text Key: 339062691
• Report Number: 19015054
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2024,01/01/2024

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
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2024
• Distributor Facility Aware Date: 01/01/2024
• Device Age: 51 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic