MAUDE Adverse Event Report: PHILIPS MRX; DEFIBRILLATOR

Device Problem No Display/Image (1183)

Patient Problem Cardiac Arrest (1762)

Event Date 06/03/2014

Event Type  Injury  

Event Description

Philips mrx screen failed during treatment for a patient in cardiac arrest.

• Brand Name: MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS; andover MA 01810
• MDR Report Key: 3866742
• MDR Text Key: 4460738
• Report Number: MW5036514
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 47 YR
• Patient Weight: 136