• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART FRX DEFIBRILLATOR AED

  • 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 NORTH AMERICA LLC HEARTSTART FRX DEFIBRILLATOR AED Back to Search Results
Model Number 861304
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Cardiac Arrest (1762)
Event Date 08/09/2021
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that the device did not shock during a patient use event and instead began analyzing again. The patient did not survive.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTSTART FRX DEFIBRILLATOR
Type of DeviceAED
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
dana tackett
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12316143
MDR Text Key266308276
Report Number3030677-2021-13592
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number861304
Device Catalogue Number453564013771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date08/09/2021
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/12/2021 Patient Sequence Number: 1
-
-