MAUDE Adverse Event Report: SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600Y

Device Problems Electromagnetic Interference (1194); Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A history review of serial number (b)(4) showed one other similar complaint from this serial number.The previous complaint for this serial number ((b)(4)) was inconclusive as the reported issue could not be reproduced during evaluation.(reference: mdr number 3006260740-2019-01929).

Event Description

The screen has rain on the bottom half, if you jiggle the strain relief or the direct connection into the back of the scanner, you can get it to go away.But, it just comes right back.They report that if you disconnect the probe and plug it back in, the image improves temporarily.

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 returned to the service facility for evaluation.During evaluation, the reported issue of the screen has rain on the bottom half , if you jiggle the strain relief or the direct connection into the back of the scanner, you can get it to go away.But, it just comes right back.They report that if you disconnect the probe and plug it back in, the image improves temporarily was confirmed.The sr8 scanner and probe were received in good physical condition.There is a lot of interference in the ultrasound box.The root cause is the probe had an internal failure.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed one other similar complaint from this serial number.The previous complaint for this serial number (b)(6) was inconclusive as the reported issue could not be reproduced during evaluation.(reference: mdr number 3006260740-2019-01929).

Event Description

The screen has rain on the bottom half , if you jiggle the strain relief or the direct connection into the back of the scanner, you can get it to go away.But, it just comes right back.They report that if you disconnect the probe and plug it back in, the image improves temporarily.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9618038
• MDR Text Key: 193308885
• Report Number: 3006260740-2020-00247
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138287
• UDI-Public: (01)00801741138287
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770600Y
• Device Catalogue Number: 9770600Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/24/2020
• 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