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

Catalog Number	9770090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will be evaluated.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
Event or Problem Description
Customer reported system freezes intermittently.Clears with reboot, then freezes again.
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: during evaluation, the reported freezing issue was confirmed.The system's front enclosure was found to be damaged, causing the reported freezing issue.Cracks found along the sides and the overall condition of the unit indicated user-related damage.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.The back enclosure was found to be cracked in several places and the probe entry cover was also broken.The coin cell battery had a charge of 1.49 v and was replaced as a precaution.No other issues were identified with the equipment.The system was serviced, tested, and returned to the customer.
Event or Problem Description
Customer reported system freezes intermittently.Clears with reboot, then freezes again.

• Brand Name: SITE-RITE PREVUE ULTRASOUND SYSTEM
• 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: 7394484
• Report Number: 3006260740-2018-00576
• Device Sequence Number: 1470217
• Product Code: ITX
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/26/2018

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 Catalogue Number: 9770090
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1