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

Catalog Number 9760036

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 root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No issue found, errors inspection and cleaning of error log and system files.A history review of serial number (b)(4) showed one other similar complaint from this serial number.The previous complaint for this serial number (b)(4) evaluation was unconfirmed as failure could not be reproduced (reference: mdr number 3006260740-2020-00962.

Event Description

Equipment freezes the display during procedure.

• Brand Name: SITE~RITE 5 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: 9921877
• MDR Text Key: 195093886
• Report Number: 3006260740-2020-01172
• Device Sequence Number: 1
• Product Code: ITX
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9760036
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/26/2016
• 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