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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 No Audible Prompt/Feedback (2282)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
It was reported to philips that there was no audio coming from the device speaker.There was no patient involvement.
 
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Brand Name
HEARTSTART MRX -EMS DEFIBRILLATOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
daniel derochers
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key10082702
MDR Text Key192143643
Report Number1218950-2020-03014
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public(01)00884838006652
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 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3536A
Device Catalogue NumberM3536A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/19/2020
Initial Date FDA Received05/22/2020
Supplement Dates Manufacturer Received05/19/2020
Supplement Dates FDA Received06/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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