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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 Failure to Shut Off (2939); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem 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
Machine will freeze screen and not shut off at times with the screen shut off prompts.
 
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 system freezing was unconfirmed.The sr8 was shut down multiple times and every time it shut down normally with no visual signs of freezing or errors.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Machine will freeze screen and not shut off at times with the screen shut off prompts.
 
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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 Key8656709
MDR Text Key146661326
Report Number3006260740-2019-01518
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 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
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 Manufacturer05/14/2019
Event Location Hospital
Date Manufacturer Received07/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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