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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE; AORTIC ULTRASOUND SCANNER
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VERATHON MEDICAL BLADDERSCAN BVI 9600 WITH AORTASCAN MODE; AORTIC ULTRASOUND SCANNER Back to Search Results
Model Number 0570-0188
Device Problems False Negative Result (1225); Low Readings (2460)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2014
Event Type  malfunction  
Event Description
The customer reported that the aortascan was giving inaccurate readings and did not register a known abdominal aortic aneurysm (aaa).There have been no adverse consequences to the patient.
 
Manufacturer Narrative
Additional device component: (b)(4).A return authorization was arranged for the customer to send the aortascan back for evaluation.To date the device has not been returned.
 
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Brand Name
BLADDERSCAN BVI 9600 WITH AORTASCAN MODE
Type of Device
AORTIC ULTRASOUND SCANNER
Manufacturer (Section D)
VERATHON MEDICAL
bothell WA
Manufacturer Contact
carmen wassell
20001 north creek parkway
bothell, WA 98011
4256295674
MDR Report Key4346724
MDR Text Key5176817
Report Number3022472-2014-00036
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 Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0570-0188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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