• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BK MEDICAL APS ENDOCAVITY BIPLANE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

  • 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
 

BK MEDICAL APS ENDOCAVITY BIPLANE TRANSDUCER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number 8848
Device Problem No Display/Image (1183)
Patient Problem Insufficient Information (4580)
Event Date 11/02/2020
Event Type  malfunction  
Event Description
Patient was prepped and draped, and procedure started when the brachytherapy probe was noted showing no image on ultrasound machine after repeated attempts by room staff and charge personnel and biomed to troubleshoot unsuccessfully. Procedure was aborted. Note, second case of the day that was cancelled. This submission is similar to report # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOCAVITY BIPLANE TRANSDUCER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BK MEDICAL APS
8 centennial dr
peabody MA 01960
MDR Report Key10958288
MDR Text Key219906446
Report Number10958288
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8848
Device Catalogue Number8848
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2020
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer12/07/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-