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 11/06/2015

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, ami 9700, catalog: 0570-0309, sn: (b)(4).

Event Description

The customer reported that during a patient procedure, using an assembly, ami 9700 console, the scanning was enlarged or inaccurate.No delay in the procedure or use of a back-up device was reported.No harm to patient or user was reported.

• 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: 5635342
• MDR Text Key: 44563373
• Report Number: 3022472-2016-00025
• 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: Recall
• Type of Report: Initial
• Report Date: 11/06/2015

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: ASSEMBLY, AMI 9700 CONSOLE
• Device Catalogue Number: 0570-0303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1091-2016
• Patient Sequence Number: 1