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: BIOSENSE WEBSTER CARDIO 3 LOCATION PAD; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  • 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
 

BIOSENSE WEBSTER CARDIO 3 LOCATION PAD; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Lot Number EM-540300
Device Problems Communication or Transmission Problem (2896); Computer Operating System Problem (2898)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2015
Event Type  malfunction  
Event Description
Pt intubated by anesthesia on cath lab table for cardiac ablation procedure.Biosense webster rep in room while receiving erratic "error" message from communication of location (magnet) pad.She tried rebooting several times and placed a call to biosense webster, who directed her that case needs to be cancelled.Dr concurred with the decision to cancel case.Pt extubated and taken to pacu in stable condition.Pt will need to be rescheduled for procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIO 3 LOCATION PAD
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BIOSENSE WEBSTER
3333 diamond canyon road
diamond bar CA 91765
MDR Report Key5096419
MDR Text Key26531716
Report Number5096419
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Report Date 09/08/2015,09/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberEM-540300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2015
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer09/08/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age68 YR
Patient Weight107
-
-