Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Failure to Capture (1081)
Patient Problem Myocardial Infarction (1969)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the heartstart mrx monitor / defibrillator failed to capture a 12-lead electrocardiogram (ecg) on a patient experiencing an event of myocardial infarction.Philips is considering this as a serious injury as the symptom resulted in a delay of therapy in a patient experiencing a myocardial infarction.The reporter stated there was no negative outcome to the patient.
 
Manufacturer Narrative
Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
Event Description
It was reported to philips that the heartstart mrx monitor / defibrillator failed to capture a 12-lead electrocardiogram (ecg) on a patient experiencing an event of myocardial infarction.Philips is considering this as a serious injury as the symptom resulted in a delay of therapy in a patient experiencing a myocardial infarction.The reporter stated there was no negative outcome to the patient.A philips field service engineer (fse) evaluated the device and was unable to duplicate the issue.The device passed all performance assurance tests and was placed back into use with the customer.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART MRX -EMS DEFIBRILLATOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key8937623
MDR Text Key155780874
Report Number1218950-2019-06470
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/02/2019
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 NumberM3536A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/02/2019
Initial Date FDA Received08/27/2019
Supplement Dates Manufacturer Received08/02/2019
Supplement Dates FDA Received06/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-