MAUDE Adverse Event Report: PHILLIPS HEALTHCARE PHILLIPS HEARTSTART MRX

Model Number HEARTSTART MRX

Device Problems Failure to Discharge (1169); Data Problem (3196); Noise, Audible (3273)

Patient Problem Cardiac Arrest (1762)

Event Date 09/17/2015

Event Type  Injury  

Event Description

Ems units responded to a possible cardiac arrest, and upon their arrival, found a (b)(6) female in cardiac arrest.Chest compressions were being performed by a family member.Ems crews continued w/cpr and applied fast patches (medstorm adult defibrillation patches), to the patient's chest showing asystole.Ccr was continued along w/insertion of intraosseous needle in left tibia and 2 doses of 1mg epinephrine given.Patient was also given 2mg of naloxone.The crew advised that they attempted to defibrillate the patient once but during the charge period, the mrx was making a strange noise, and would not discharge to the patient when the shock button was pressed.The crew was concerned with the monitor so they applied an aed that was on scene.They advised the aed did not advise to shock.After 15 minutes of ccr w/no changes, contact w/medical control was made and orders were received to cease resuscitation.After the call, crew members tried to retrieve information from the mrx monitor, and the only data that was received was approximately 8 seconds of the initial call.Unable to retrieve further data.

• Brand Name: PHILLIPS HEARTSTART MRX
• Manufacturer (Section D): PHILLIPS HEALTHCARE; andover MA 01810
• MDR Report Key: 5235770
• MDR Text Key: 31681845
• Report Number: 5235770
• Device Sequence Number: 1
• Product Code: DPS
• 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: 09/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HEARTSTART MRX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/17/2015
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR
• Patient Weight: 77