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 MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS 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 MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR Back to Search Results
Model Number 861290
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
 
Event Description
The customer called into philips to report that the monitor/screen is stuck/locked, here was no reported patient involvement/adverse patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
ALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
betty harris
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key7437347
MDR Text Key105784162
Report Number1218950-2018-03477
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public(01)00884838023680
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/21/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-