MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE PREVUE+ ULTRASOUND SYSTEM REFURB SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770086R

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Type  malfunction  

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 Description

Per biomed: sr prevue+ sn: (b)(4) has a damaged probe strain relief and the system intermittently "locks up" and the system needs to be restarted to get it to function again.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of the prevue+ system freezing was inconclusive because the clinical setting nor the reported issue could be reproduced. The equipment was returned and assessed by the manufacture site. The manufacture site reported that the scanner passed functional testing requirements. Reference cesc rec (b)(4) for complete evaluation and servicing details. The returned system did not display the behavior reported by the complainant and it is likely that the event was caused by another root cause. A history review of serial number dyybq049 showed no other similar complaint(s) from this serial number.

Event Description

Per biomed: sr prevue+ sn: (b)(4) has a damaged probe strain relief and the system intermittently "locks up" and the system needs to be restarted to get it to function again.

• Brand Name: SITE~RITE PREVUE+ ULTRASOUND SYSTEM REFURB
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7322418
• MDR Text Key: 101973816
• Report Number: 3006260740-2018-00393
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 9770086R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse