MAUDE Adverse Event Report: VERATHON MEDICAL ASSEMBLY, AMI 9700 CONSOLE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number ASSEMBLY, AMI 9700 CONSOLE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2013

Event Type  malfunction  

Manufacturer Narrative

This product was received for evaluation and the reported failure was confirmed by tech services.The shorted scan cable was replaced and the probe's pcba & dcm were upgraded.Additional part used: assy, probe, ami 9700; catalog: 0570-0309; sn: (b)(4).

Event Description

The customer reported that during a patient procedure, using an assembly, ami 9700 console, only white lines showed up on one side of the monitor and the other side was blank.A phantom was scanned and no reading was obtained.

• Brand Name: ASSEMBLY, AMI 9700 CONSOLE
• 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: 5630622
• MDR Text Key: 44385077
• Report Number: 3022472-2016-00009
• 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: Physician
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 07/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSEMBLY, AMI 9700 CONSOLE
• Device Catalogue Number: 0570-0303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2013
• 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