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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 ULTRASOUND SYSTEM BEDSIDE VAD ROLL STAND ULTRASOUND PULSED ECHO IMAGING SYSTEM; DIAGNOSTIC ULTRASONIC TRANSDUCERS

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BARD ACCESS SYSTEMS SITE~RITE 6 ULTRASOUND SYSTEM BEDSIDE VAD ROLL STAND ULTRASOUND PULSED ECHO IMAGING SYSTEM; DIAGNOSTIC ULTRASONIC TRANSDUCERS Back to Search Results
Model Number N/A
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Electric Shock (2554)
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 following were reviewed as part of this investigation: patient severity, trend analysis, 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 root cause of the reported complaint regarding electric shock is inconclusive as evaluation of the photo sample indicates that the roll stand has been modified by the user. Root cause of the shock could not be definitively determined without physical evaluation of the equipment. Manufacturing records for the scanner were also reviewed and no potential contributing factors were found during manufacture and quality inspection of the scanner a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Facility stated that it was reported by the picc rn's that they receive a hard electric shock when using the site rite 6 attached to a gcx stand. Images show that the stand has been modified with unidentified equipment and a power strip.
 
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 evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Facility stated that it was reported by the picc rn's that they receive a hard electric shock when using the site rite 6 attached to a gcx stand. Images show that the stand has been modified with unidentified equipment and a power strip.
 
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Brand NameSITE~RITE 6 ULTRASOUND SYSTEM BEDSIDE VAD ROLL STAND
Type of DeviceULTRASOUND PULSED ECHO IMAGING SYSTEM; DIAGNOSTIC ULTRASONIC TRANSDUCERS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6784255
MDR Text Key107245197
Report Number3006260740-2017-01261
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071204
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number9772001
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/15/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

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