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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL AORTASCAN AMI 9700
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VERATHON MEDICAL AORTASCAN AMI 9700 Back to Search Results
Model Number 0570-0352
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2015
Event Type  malfunction  
Event Description
The customer reported that the aortascan was giving inaccurate readings.There were conflicting readings on the same patient, with one measurement of > 6 cm, and another measurement of < 3 cm in the same location.No adverse consequence to the patient was reported.
 
Manufacturer Narrative
Additional device component: ami 9700 console (b)(4).Repeated attempts have been made to contact the customer and obtain further details on the complaint, including how they are using the device, whether they can provide additional test results.The customer has not responded to these requests.
 
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Brand Name
AORTASCAN AMI 9700
Manufacturer (Section D)
VERATHON MEDICAL
bothell WA
Manufacturer Contact
carmen wassell
20001 n creek pkwy
bothell, WA 98011
4256295674
MDR Report Key4534608
MDR Text Key5515730
Report Number3022472-2015-00007
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 Other
Type of Report Initial
Report Date 01/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0570-0352
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2015
Initial Date FDA Received02/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
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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