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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

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PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Pacing Problem (1439)
Patient Problems Loss Of Pulse (2562); No Code Available (3191)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: a follow up report will be submitted upon completion of the investigation.
 
Event Description
The customer reported that during treatment of a patient in cardiac arrest, when the users attempted to pace a patient, only dashed lines were displayed. The patient was initially in pea (pulseless electrical activity) but with treatment had a return of pulses with a rhythm of svt (supraventricular tachycardia). The patient was then sync cardioverted to a sinus tachycardia. The patient¿s rhythm then changed to a sinus bradycardia and the users prepared to pace the patient. As they prepared to pace, only dashed lines were displayed and the patient then lost pulses. When dashed lines are displayed, it means that no ecg input from that source is being received. After checking the mrx device connections and finding no problems, they switched to an fr3 defibrillator to continue care of the patient. The patient regained pulses and the patient was switched back to the mrx device, ecg leads were placed and the patient was in svt again. A second sync cardioversion was performed converting the patient to a sinus tachycardia and the patient was transported to the hospital. The care of the patient was transferred to emergency hospital staff. The same defibrillator pads were in use during the event and were not changed or removed. The only reference to the application of ecg leads was near the end of the event when the patient was switched back to the mrx prior to the second sync cardioversion. Philips has requested additional information related to this event. We are considering this to be a serious injury based on the interruption of planned treatment and the change to a different device. Although the users could not initiate pacing with the mrx, the patient then regained pulses and pacing was no longer required. The mrx device successfully delivered two cardioversion shocks converting the patient rhythm. There was no attempt to deliver therapy with the fr3 device as there was not a need for defibrillation during this event including the time the patient was on the fr3 device.
 
Event Description
The customer reported that during treatment of a patient in cardiac arrest, when the users attempted to pace a patient, only dashed lines were displayed. We are considering this to be a serious injury based on the interruption of planned treatment and the change to a different device. Although the users could not initiate pacing with the mrx, the patient then regained pulses and pacing was no longer required. The mrx device successfully delivered two cardioversion shocks converting the patient rhythm. There was no attempt to deliver therapy with the fr3 device as there was not a need for defibrillation during this event including the time the patient was on the fr3 device. A philips clinician evaluated the case events file and ecg strips related to the event. The patient was initially in pea (pulseless electrical activity) but with treatment had a return of pulses with a rhythm of svt (supraventricular tachycardia). The patient was then sync cardioverted to a sinus tachycardia. The patient¿s rhythm then changed to a sinus bradycardia and the users prepared to pace the patient. As they prepared to pace, only dashed lines were displayed and the patient then lost pulses. When dashed lines are displayed, it means that no ecg input from that source is being received. After checking the mrx device connections and finding no problems, they switched to an fr3 defibrillator to continue care of the patient. The patient regained pulses and the patient was switched back to the mrx device, ecg leads were placed and the patient was in svt again. A second sync cardioversion was performed converting the patient to a sinus tachycardia and the patient was transported to the hospital. The care of the patient was transferred to emergency hospital staff. The same defibrillator pads were in use during the event and were not changed or removed. The only reference to the application of ecg leads was near the end of the event when the patient was switched back to the mrx prior to the second sync cardioversion. A philips field service engineer (fse) evaluated the device. The fse tested the device¿s pacer function and found no malfunction. No errors were found in the device status log. Philips was unable to duplicate the reported problem. The device retested and placed back into service after the device evaluation and an acknowledgement letter was sent to the customer. The information gathered for this report does not provide evidence of a systemic, design, or labeling problem. No further investigation or action is warranted.
 
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Brand NameHEARTSTART MRX -EMS DEFIBRILLATOR
Type of DeviceDEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
laura scanlan
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8659845
MDR Text Key146701893
Report Number1218950-2019-03926
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/05/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/19/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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