• 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 XL+ DEFIBRILLATOR/MONITOR

  • 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 XL+ DEFIBRILLATOR/MONITOR Back to Search Results
Model Number 861290
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device is getting artifacts in the ecg. The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of DeviceDEFIBRILLATOR
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 Key12715949
MDR Text Key279026687
Report Number3030677-2021-15289
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-