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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 Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
The customer reported the device would not detect monitored hr (heart rate) from patient with a pacemaker. The device was in use on a patient, however there was no adverse event to the patient or user.
 
Event Description
The customer reported the device would not detect monitored hr (heart rate) from patient with a pacemaker. The device was in use on a patient, however there was no adverse event to the patient or user. During the event, emergency medical services arrived on scene, and connected the patient to a heartstart mrx via ecg electrodes. Relevant medical history included status post placement of an automated implantable cardioverter defibrillator. No shocks were attempted or delivered during the event. No transcutaneous pacing was attempted or delivered during the event. No adverse event was reported or associated with the use of this device. Electrocardiogram (ecg) rhythm strips and case events file were provided for review. Review of provided electrocardiogram (ecg) rhythm strips and case events showed the heartstart mrx was powered on into monitor mode with patient category set to non-paced at 09:17:13 on (b)(6) 2018. At 00:01 elapsed time (et), ecg leads were placed with lead ii selected as the source ecg. Throughout the entire rhythm strip, the patient had a paced heart rhythm of approximately 80 paced pulses per minute (ppm). The heartstart mrx would calculate the rhythm as an extreme bradycardia. A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom. There is no information to support that a malfunction occurred. The device was behaving as intended when it would not count the paced pulses as the heart rate. The algorithm counting r waves, not pacer spikes, is an expected device behavior.
 
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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 (Section G)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer Contact
jacqueline nishino
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8171447
MDR Text Key130619333
Report Number1218950-2018-09799
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2014
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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