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

Model Number 9770600

Device Problems Premature Discharge of Battery (1057); Loss of Power (1475); Battery Problem (2885)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation. A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number. Device has not been received, at this time.

Event Description

Per tm - unit is shutting down mid-procedure with 50% battery life. It starts at about 97% then runs for an hour and shuts down indicating 56% left.

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 scanner shuts off fifty percent of life was confirmed. During inspection the scanner shuts down prematurely after ac power is removed, the cause of the issue is due to an internal li-ion battery failure. No other functionality issues with the equipment were found during evaluation/servicing. The device was serviced, tested, and returned to the customer. A history review of serial number: (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - unit is shutting down mid-procedure with 50% battery life. It starts at about 97% then runs for an hour and shuts down indicating 56% left.

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 scanner shuts off fifty percent of life was confirmed. During inspection the scanner shuts down prematurely after ac power is removed, the cause of the issue is due to an internal li-ion battery failure. No other functionality issues with the equipment were found during evaluation/servicing. The device was serviced, tested, and returned to the customer. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm - unit is shutting down mid-procedure with 50% battery life. It starts at about 97% then runs for an hour and shuts down indicating 56% left.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
• 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: 8717326
• Report Number: 3006260740-2019-01697
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138263
• UDI-Public: (01)00801741138263
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9770600
• Device Catalogue Number: 9770600
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C