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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILLIPS HEALTHCARE PHILLIPS HEARTSTART MRX

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PHILLIPS HEALTHCARE PHILLIPS HEARTSTART MRX Back to Search Results
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.

 
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Brand NamePHILLIPS HEARTSTART MRX
Manufacturer (Section D)
PHILLIPS HEALTHCARE
andover MA 01810
MDR Report Key5235770
MDR Text Key31681845
Report Number5235770
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received09/23/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberHEARTSTART MRX
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/25/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date09/17/2015
Event Location AMBULATORY SURGICAL Facility
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/23/2015 Patient Sequence Number: 1
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