MAUDE Adverse Event Report: VERATHON MEDICAL BVI 9600; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number BVI 9600

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Technical services tested the unit and confirmed the inaccurate readings with 0ml probe readings and <3.0 cm aorta readings.Capa (b)(4) was implemented to improve the wire crimping process in manufacture of the cable.This addressed the problem with shorting and stress on pins within the probe.Printing of strange images could not be confirmed.Additional repairs were conducted to replace the cracked top and bottom probe cover, evaluated to be the result of customer use.The data collection module and printed circuit board assembly were replaced and the repaired unit returned to the customer.

Event Description

Customer reports that the device is showing inaccurate aorta scans and is printing strange images.There was no patient harm reported.

• Brand Name: BVI 9600
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011
• Manufacturer Contact: brian anderson ; 20001 north creek parkway; bothell, WA 98011 ; 4256295674
• MDR Report Key: 5153801
• MDR Text Key: 28415845
• Report Number: 3022472-2015-00031
• 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: Other
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BVI 9600
• Device Catalogue Number: 0570-0212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1