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

Model Number 0570-0303

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

This product has not been received for evaluation, therefore the problem cannot be confirmed.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 ami 9700 console assembly, the device was reading inaccurately; giving false positives / negatives.No delay in the procedure or use of a back-up device was reported.No harm to patient or user was reported.

• Brand Name: AMI 9700 CONSOLE ASSEMBLY
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON MEDICAL; 20001 n creek pkwy; bothell WA 98011 8218
• Manufacturer Contact: kent huthsing ; 20001 north creek pkwy; bothell, WA 98011-8218 ; 4258671348
• MDR Report Key: 5693211
• MDR Text Key: 46363141
• Report Number: 3022472-2016-00031
• 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
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0303
• Device Catalogue Number: 0570-0303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1