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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770600
Device Problems Image Display Error/Artifact (1304); Poor Quality Image (1408)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.Supplemental will be submitted with evaluation results.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per biomed: diminishing screen image quality.
 
Event Description
Per biomed: diminishing screen image quality.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.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 diminishing screen image quality was unconfirmed.During evaluation the scanner was evaluated with the model 550 phantom and the image was found to be normal.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The device was serviced, tested and returned to the customer.A history review of serial number (b)(6).Showed no other similar product complaint(s) from this serial number.
 
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Brand Name
SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
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 Key8717251
MDR Text Key148818655
Report Number3006260740-2019-01694
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 user facility
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770600
Device Catalogue Number9770600
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Event Location Hospital
Initial Date Manufacturer Received 05/28/2019
Initial Date FDA Received06/20/2019
Supplement Dates Manufacturer Received09/12/2019
Supplement Dates FDA Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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