MAUDE Adverse Event Report: PHILLIPS NORTH AMERICA LLC PHILLIPS MX40 (TELEMETRY) AND CENTRAL MONITORS ; DETECTOR, AND ALARM, ARRHYTHMIA

Model Number MX40

Device Problem Device Alarm System (1012)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 03/02/2020

Event Type  Death  

Event Description

Alarm did not sound when pt was in bradycardia and pt subsequently coded and expired.

• Brand Name: PHILLIPS MX40 (TELEMETRY) AND CENTRAL MONITORS
• Type of Device: DETECTOR, AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): PHILLIPS NORTH AMERICA LLC ; 3000 minute man rd; andover MA 01810
• MDR Report Key: 9823481
• MDR Text Key: 183260705
• Report Number: MW5093679
• Device Sequence Number: 1
• Product Code: DSI
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MX40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 71