• 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 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 NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problem Output below Specifications (3004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
Event Type  malfunction  
Event Description
Philips received a complaint on the heartstart mrx indicating that the device fails operational testing.There was no patient involvement.The fse evaluated the device.The device requires high voltage capacitor replacement.The device is unable to achieve value of load in accordance with use according to the manufacturer's specifications.Due to the equipment being in end-of-life (eol), it is not possible to provide material for the capacitor replacement.The device registers as inoperable.Based on the information available and the testing conducted, the cause of the reported problem is a malfunctioning high voltage capacitor.The reported problem was confirmed.The device after being evaluated needs a high voltage capacitor which is no longer available due to the device being eol since 31 december 2022.The device needs to remain out of service.The investigation concludes that no further action is required at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART MRX -EMS DEFIBRILLATOR
Type of Device
DEFIBRILLATOR
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
tanya deschmidt
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key18100554
MDR Text Key327717803
Report Number3030677-2023-04457
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public00884838006652
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
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
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-