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

Model Number 9770090

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 Description

Per tm - screen has gone blank on this unit.

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 Description

Per tm - screen has gone blank on this unit.

• Brand Name: SITE-RITE PREVUE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8781771
• MDR Text Key: 150816466
• Report Number: 3006260740-2019-01921
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• Combination Product (y/n): N
• PMA/PMN Number: K120882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1