MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - the picture quality changes mid procedure and being extremely grainy.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: product was not returned for evaluation/repair.Complaint investigation and root cause determination could not be completed without physical evaluation of the unit.The device was returned to the service facility for evaluation.During evaluation, the reported issue of the picture quality changes mid procedure and being extremely grainy is unconfirmed.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The scanner image is normal and functions normally.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - the picture quality changes mid procedure and being extremely grainy.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9373561
• MDR Text Key: 168468057
• Report Number: 3006260740-2019-03716
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138263
• UDI-Public: (01)00801741138263
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

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: 9770600
• Device Catalogue Number: 9770600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 04/19/2020
• Supplement Dates FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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