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 NORTH AMERICA LLC HEARTSTART MRX ALS MONITOR; 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 ALS MONITOR; DEFIBRILLATOR Back to Search Results
Model Number M3536A
Device Problems Electrical /Electronic Property Problem (1198); Failure to Read Input Signal (1581)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device failed to recognize the installed test load and the therapy cable.There was no patient involvement.
 
Manufacturer Narrative
Provided device evaluation and coding.
 
Event Description
It was reported to philips that the device failed to recognize the installed test load and the therapy cable.The customer requested that an authorized field service engineer (fse) be dispatched to the customer site.Upon evaluation of the device, the reported issue was confirmed and the cause was traced to a faulty processor pca.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the processor pca.The processor pca was replaced and the device was deemed fit for use.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART MRX ALS MONITOR
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
MDR Report Key12329347
MDR Text Key266840978
Report Number3030677-2021-13641
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838006652
UDI-Public00884838006652
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
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
Distributor Facility Aware Date07/20/2021
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-