MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE PREVUE ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	9770090
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.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 or Problem Description
Per biomed - unit has an artifact down the middle of the screen.
Additional 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 unit has an artifact down the middle of the screen was confirmed.The scanner was inspected the lcd display is damaged and displaying vertical lines within the display, the cause of the issue is due to a damaged lcd display.The device was serviced, tested and returned to the customer.A history review of serial number dywhe018 showed one other similar complaint from this serial number.Both complaints for this serial number (b)(6) have been reported from same facility.
Event or Problem Description
Per biomed - unit has an artifact down the middle of the screen.

• Brand Name: SITE-RITE PREVUE ULTRASOUND
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9467639
• Report Number: 3006260740-2019-03839
• Device Sequence Number: 1835128
• Product Code: IYO
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K120882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 9770090
• Device Catalogue Number: 9770090
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1