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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
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.
 
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Brand NameSITE~RITE 8 ULTRASOUND SYSTEM
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7376076
MDR Text Key103920919
Report Number3006260740-2018-00529
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 user facility
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 Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770500
Device Catalogue Number9770500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2018
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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