• 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 MRX AIRWORTHY; DRO LLD MKJ

  • 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 MRX AIRWORTHY; DRO LLD MKJ Back to Search Results
Model Number 861464
Device Problem Failure to Power Up (1476)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
The customer reported that the device failed to power on.There was no patient impact.
 
Manufacturer Narrative
(b)(4).A follow up report will be submitted upon completion of the investigation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART MRX AIRWORTHY
Type of Device
DRO LLD MKJ
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810 109
Manufacturer Contact
nancy ataide
3000 minuteman road
andover, MA 01810
9786597429
MDR Report Key3772855
MDR Text Key4433649
Report Number1218950-2014-00110
Device Sequence Number1
Product Code DRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861464
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/13/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-