MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770500

Device Problems Loss of Power (1475); Battery Problem (2885)

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 is shutting down without command and is making a strange beeping sound while in a grey screen.System is shutting down on the users during procedures.

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 shutting down during use could not be reproduced.The scanner was evaluated and no malfunctions were found.The scanner was left running overnight and did not shut down during this time.The run-time was checked and the scanner ran on battery power for approximately 3 hours.The root cause of the reported system shutting down during use is inconclusive as neither the reported issue nor the clinical setting could be reproduced during evaluation.It is likely that the cause of the failure is not attributed to any malfunction on the equipment.Manufacturing reviews were performed and the results do not indicate a manufacturing issue.No additional issues were found with the equipment.The scanner was serviced, tested, and shipped to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Customer reported system is shutting down without command and is making a strange beeping sound while in a grey screen.System is shutting down on the users during procedures.

Event Description

Customer reported system is shutting down without command and is making a strange beeping sound while in a grey screen.System is shutting down on the users during procedures.

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 shutting down during use could not be reproduced.The scanner was evaluated and no malfunctions were found.The scanner was left running overnight and did not shut down during this time.The run-time was checked and the scanner ran on battery power for approximately 3 hours.The root cause of the reported system shutting down during use is inconclusive as neither the reported issue nor the clinical setting could be reproduced during evaluation.It is likely that the cause of the failure is not attributed to any malfunction on the equipment.Manufacturing reviews were performed and the results do not indicate a manufacturing issue.No additional issues were found with the equipment.The scanner was serviced, tested, and shipped to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 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
• MDR Report Key: 7376076
• MDR Text Key: 103920919
• Report Number: 3006260740-2018-00529
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770500
• Device Catalogue Number: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 08/13/2018; 10/11/2019
• Supplement Dates FDA Received: 08/28/2018; 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1