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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
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.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7493059
MDR Text Key107635372
Report Number3006260740-2018-00910
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
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 Received05/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2243072-10/11/2019-013-C

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