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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASUND SYSTEM W/PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASUND SYSTEM W/PINPOINT GT; 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
Sr 8 ultrasound system shuts down mid-procedure.Battery doesn't seem to be the cause of the loss of power because the system boots to a 50% battery level.
 
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 unit system shutdown during use was confirmed and the cause is an internal failure in the lithium-ion battery.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 1 hour and shut down with the battery showing a 50% charge.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, repaired and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Sr 8 ultrasound system shuts down mid-procedure.Battery doesn't seem to be the cause of the loss of power because the system boots to a 50% battery level.
 
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 unit system shutdown during use was confirmed and the cause is an internal failure in the lithium-ion battery.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 1 hour and shut down with the battery showing a 50% charge.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, repaired and returned to the customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Sr 8 ultrasound system shuts down mid-procedure.Battery doesn't seem to be the cause of the loss of power because the system boots to a 50% battery level.
 
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Brand Name
SITE-RITE 8 ULTRASUND SYSTEM W/PINPOINT GT
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 Key7613697
MDR Text Key111997595
Report Number3006260740-2018-01431
Device Sequence Number1
Product Code ITX
UDI-Device Identifier00801741098338
UDI-Public(01)00801741098338
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
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 Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770501
Device Catalogue Number9770501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
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
Patient Sequence Number1
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