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: VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
  • 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
 

VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE Back to Search Results
Model Number 0570-0351
Device Problems False Negative Result (1225); Low Readings (2460)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2014
Event Type  malfunction  
Event Description
The customer reported that the aortascan gave inaccurate readings of < 3 cm on two patients; no comparison tests were completed by the customer on either pt to verify inaccuracy.There was no adverse event with either pt.
 
Manufacturer Narrative
No pt adverse event.Testing at verathon showed that the device was reading < 3 cm on a 3.7 cm aorta phantom.The dcm (data collection module) in the scanning probe did not work, and had to be replaced.The device scanned accurately after repair of the probe.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
Manufacturer (Section D)
VERATHON MEDICAL
bothell WA
Manufacturer Contact
adam gaines
20001 north creek pkwy
bothell, WA 98011
4256295606
MDR Report Key4095587
MDR Text Key4836653
Report Number3022472-2014-00032
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082456
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0570-0351
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/26/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-