MAUDE Adverse Event Report: VERATHON MEDICAL ASSY, CONSOLE, BVI9600; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number ASSY, CONSOLE, BVI9600

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2015

Event Type  malfunction  

Manufacturer Narrative

This product has not been received for evaluation at the time of this report.The problem cannot be confirmed.If the suspect device is returned a supplemental report will be issued with the results of the evaluation.Additional part used: assy, probe, bvi 9400/9600; catalog: 0570-0351; sn: (b)(4).

Event Description

The customer reported that during a patient procedure, using a assy, console, bvi9600, the dr.Got inaccurate aorta readings.Dr.Found multiple patients with aaas in the last few weeks and sent them in for ct scans and found either no aaas or small ones.No delay in the procedure or use of a back-up device was reported.No harm to patient or user was reported.

• Brand Name: ASSY, CONSOLE, BVI9600
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• Manufacturer Contact: brian anderson ; 20001 north creek parkway; bothell, WA 98011-8218 ; 4256295674
• MDR Report Key: 5635298
• MDR Text Key: 44555675
• Report Number: 3022472-2016-00006
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSY, CONSOLE, BVI9600
• Device Catalogue Number: 0570-0212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 3022472-100915-001-C
• Patient Sequence Number: 1