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

Model Number	9770090R
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
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 dyyke018 showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed the scanner freezes up.
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 scanner freezing was confirmed.The scanner was inspected and boots up to a blank acoustic screen, the cause of the issue is due to a failure in the probe.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per biomed- the scanner freezes up.

• Brand Name: REFURB, 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: 9152773
• Report Number: 3006260740-2019-02928
• Device Sequence Number: 2694169
• Product Code: IYO
• UDI-Device Identifier: 00801741124938
• UDI-Public: (01)00801741124938
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150529
• 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): 12/19/2019

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: 9770090R
• Device Catalogue Number: 9770090R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1