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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, US; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, US; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770600
Device Problems No Display/Image (1183); Power Problem (3010)
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
Biomed reported the sr8 system's screen is blank.Peripheral lights, bard logo, and green power light were reported to come on, but nothing appears on the screen.Biomed later updated that the system powered up normally after multiple reboots.However, users have mentioned that the system's screen has blanked out during use.
 
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 system's screen is blank/failure to boot was confirmed.The scanner boots to a black screen.The root cause is a loose connection on the lvds cable.The device was serviced, tested and returned to customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Biomed reported the sr8 system's screen is blank.Peripheral lights, bard logo, and green power light were reported to come on, but nothing appears on the screen.Biomed later updated that the system powered up normally after multiple reboots.However, users have mentioned that the system's screen has blanked out during use.
 
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Brand Name
SITE-RITE 8 ULTRASOUND SYSTEM, US
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 Key7873265
MDR Text Key120292909
Report Number3006260740-2018-02431
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138263
UDI-Public(01)00801741138263
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770600
Device Catalogue Number9770600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2018
Event Location Hospital
Date Manufacturer Received08/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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