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

Model Number ASSY, AMI 9700 CONSOLE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

Technical services evaluated the returned product and could not confirm the reported issues.All scans were within published ranges.Unit's dcm was replaced/upgraded and the unit was returned to customer.Additional part used: assy, probe, ami 9700 (pre-copq); catalog: 0570-0309; sn: (b)(4).

Event Description

The customer reported that during a patient procedure, using an ami 9700 console with probe, the unit reports inaccurate readings.No back-up device was reportedly used.No delay in the procedure was noted.No harm to patient or user was reported.

• Brand Name: ASSY, 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: 5472447
• MDR Text Key: 39418163
• Report Number: 3022472-2016-00005
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASSY, AMI 9700 CONSOLE
• Device Catalogue Number: 0570-0303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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