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

Model Number 9770600

Device Problem Delayed Program or Algorithm Execution (4034)

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 one other similar complaint from this serial number.Both complaints for this serial number ((b)(4)) have been reported from same facility.

Event Description

Per biomed - the machine will take a couple tries to turn on, iv placements, the image is delayed, 3cg & sherlock delays.

Manufacturer Narrative

H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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: the device was retuned to the service facility for evaluation.During evaluation, the reported issue of machine will take a couple tries to turn on, iv placements, the image is delayed, 3cg & sherlock delays was unconfirmed.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The scanner was inspected it booted up with no error, it was tested with in-house sherlock unit without delays.A history review of serial number (b)(4) showed one other similar complaint from this serial number.Both complaints for this serial number (b)(4) have been reported from same facility.

Event Description

Per biomed - the machine will take a couple tries to turn on, iv placements, the image is delayed, 3cg & sherlock delays.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9373515
• MDR Text Key: 168467982
• Report Number: 3006260740-2019-03707
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 11/26/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/07/2020
• 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