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

Catalog Number 9763000

Device Problem Computer Operating System Problem (2898)

Patient Problem No Information (3190)

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 device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.Device not returned.

Event Description

It was reported that the power may be turned off during use.Additional information supplied on (b)(6) 2018: "even if the hospital does not operate anything, this site light will be powered down.It seems that the screen becomes dark and the power supply is dropped in a state with charging.".

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 issue of the system powering-off or becoming dark during use could not be reproduced.The scanner powers on, boots up normally and has a good image for the current version of software.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.No other issues with the equipment were found during evaluation.The sr5 was serviced, qc tested, and returned to the customer.

Event Description

It was reported that the power may be turned off during use.04/25/2018 additional information: "even if the hospital does not operate anything, this site light will be powered down.It seems that the screen becomes dark and the power supply is dropped in a state with charging.".

• Brand Name: SITE-RITE 5-EX 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. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7508667
• MDR Text Key: 108139971
• Report Number: 3006260740-2018-00958
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741091032
• UDI-Public: (01)00801741091032
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• 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: 05/11/2018
• 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: 04/05/2018
• 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