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

Catalog Number 9770090

Device Problems Intermittent Continuity (1121); Operating System Becomes Nonfunctional (2996)

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

Customer reported system freezes intermittently.Clears with reboot, then freezes again.

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 Description

Customer reported system freezes intermittently.Clears with reboot, then freezes again.

• Brand Name: SITE-RITE PREVUE ULTRASOUND SYSTEM
• 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: 7394484
• MDR Text Key: 104429470
• Report Number: 3006260740-2018-00576
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741091056
• UDI-Public: (01)00801741091056
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/24/2018
• 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
• Patient Sequence Number: 1