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

Model Number 9770501

Device Problems Loss of Power (1475); 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 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

Multiple instances of the ultrasound system shutting down mid-procedure w/o obvious cause. At three noted shut downs the system was noted to have a 40+% charge. The 1st shut-down was just after the rn cleaned the patients stick site and put the probe back on the arm to assess a vascular structure. The system was booted back up and noted at a 42% charge. The rn re-entered the patient data and accessed the vein and had the guide wire only inserted when the system shut down again. The unit was rebooted and had a 40% charge. The system was then taken to the picc office and the stored images were being transferred to pacs and the system shut down again.

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 the unit shutting down multiple times without cause or low battery was confirmed. The problem is confirmed; the scanner was charged to 100%, when the ac adaptor was removed the scanner ran for approximately 20 minutes. The root cause is an internal failure in the lithium-ion battery. No other functionality issues with the equipment were found during evaluation/servicing. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Multiple instances of the ultrasound system shutting down mid-procedure w/o obvious cause. At three noted shut downs the system was noted to have a 40+% charge. The 1st shut-down was just after the rn cleaned the patients stick site and put the probe back on the arm to assess a vascular structure. The system was booted back up and noted at a 42% charge. The rn re-entered the patient data and accessed the vein and had the guide wire only inserted when the system shut down again. The unit was rebooted and had a 40% charge. The system was then taken to the picc office and the stored images were being transferred to pacs and the system shut down again.

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 the unit shutting down multiple times without cause or low battery was confirmed. The problem is confirmed; the scanner was charged to 100%, when the ac adaptor was removed the scanner ran for approximately 20 minutes. The root cause is an internal failure in the lithium-ion battery. No other functionality issues with the equipment were found during evaluation/servicing. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Multiple instances of the ultrasound system shutting down mid-procedure w/o obvious cause. At three noted shut downs the system was noted to have a 40+% charge. The 1st shut-down was just after the rn cleaned the patients stick site and put the probe back on the arm to assess a vascular structure. The system was booted back up and noted at a 42% charge. The rn re-entered the patient data and accessed the vein and had the guide wire only inserted when the system shut down again. The unit was rebooted and had a 40% charge. The system was then taken to the picc office and the stored images were being transferred to pacs and the system shut down again.

• 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: 7493059
• MDR Text Key: 107635372
• Report Number: 3006260740-2018-00910
• Device Sequence Number: 1
• Product Code: ITX
• 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,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9770501
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018

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