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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE 6; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BARD ACCESS SYSTEMS REFURB, SITE-RITE 6; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number N/A
Device Problems Loss of Power (1475); Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) found a similar complaint reported on record number (b)(4).The root cause was found to be a loose lvds (video) cable.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.
 
Event Description
It was reported by materials manager that site rite 6 ultrasound system is shutting down intermittently during use.Sometimes they can smack it and it turns back on, sometimes they have to actually turn it off and back on a couple of times.
 
Event Description
It was reported by materials manager that site rite 6 ultrasound system is shutting down intermittently during use.Sometimes they can smack it and it turns back on, sometimes they have to actually turn it off and back on a couple of times.
 
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 unit is shutting down intermittently is unconfirmed.The scanner was run for 18 continuous hours with both usb ports occupied.No intermittent shut down was detected.The error log was checked and is empty of any errors related to the problem.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) found a similar complaint reported on record number 875742.The root cause was found to be a loose lvds (video) cable.
 
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Brand Name
REFURB, SITE-RITE 6
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 Key7770931
MDR Text Key116860325
Report Number3006260740-2018-02035
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K071204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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 Received08/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number9770066R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2018
Event Location Hospital
Date Manufacturer Received08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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