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

Model Number 9770500

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); 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 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.

Event Description

It was reported that the sr 8 system shuts down without command mid-procedure; at reboot the battery shows a proper charge on the display.

Event Description

It was reported that the sr 8 system shuts down without command mid-procedure; at reboot the battery shows a proper charge on the display.

Manufacturer Narrative

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.

• Brand Name: SITE-RITE 8 ULTRASOUND
• 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: 7563248
• MDR Text Key: 109932185
• Report Number: 3006260740-2018-01204
• Device Sequence Number: 1
• Product Code: IYO
• 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: health professional,user faci
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

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?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1