MAUDE Adverse Event Report: PHILIPS HEALTHCARE PHILIPS MRX; CARDIAC MONITOR / DEFIBRILLATOR

Model Number M3536A

Device Problem Failure to Capture (1081)

Patient Problems Bradycardia (1751); Bradycardia (1751); Death (1802); Tachycardia (2095); Tachycardia (2095); Loss of consciousness (2418); Loss of consciousness (2418); Lethargy (2560); Lethargy (2560)

Event Date 05/21/2018

Event Type  Death  

Event Description

Monitor failed to recognize pads and pace, amplitude would not increase to allow capture.Pt upon arrival was aax1, lethargic.Pt carried to unit, found to have a tachycardic rhythm.After approx 2 mins, pt became unresponsive, heart rhythm changed to bradycardia.Pacer pads put on pt, monitor stated to connect pads and pads cable.When monitor switched to pacer mode, amplitude selection would not change from 10ma.Capture was not possible.

• Brand Name: PHILIPS MRX
• Type of Device: CARDIAC MONITOR / DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS HEALTHCARE ; andover MA
• MDR Report Key: 8536657
• MDR Text Key: 241261925
• Report Number: 8536657
• Device Sequence Number: 1
• Product Code: MKJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2018
• Device Age: 12 YR
• Event Location: Home
• 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: 0
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 46