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

Model Number	9770090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 no other similar product complaint(s) from this serial number.
Event or Problem Description
Per tm - screen has gone blank on this unit.
Additional 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: the device was returned to the service facility for evaluation.During evaluation, the reported issue of the screen has gone blank is confirmed, due to an internal failure in the beamformer pcb.The device was serviced, tested and returned to refurbished inventory.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per tm - screen has gone blank on this unit.

• Brand Name: SITE-RITE PREVUE
• 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: 8781771
• Report Number: 3006260740-2019-01921
• Device Sequence Number: 1668739
• Product Code: IYO
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 07/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1