MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number 9763000

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 system stops and freezes the image is unconfirmed.The reported issue could not be confirmed, since it was an intermittent problem, it was not possible to identify the failure.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported that the system stops and freezes the image.Intermittent problem.

• Brand Name: SITE~RITE 5 ULTRASOUND SYSTEM CLASS II SCANNER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 9860416
• MDR Text Key: 194814095
• Report Number: 3006260740-2020-00962
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741091032
• UDI-Public: (01)00801741091032
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9763000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/13/2016
• 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