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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REFURB, SITE-RITE 8 ULTRASOUND AND ACCESSORIES

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BARD ACCESS SYSTEMS REFURB, SITE-RITE 8 ULTRASOUND AND ACCESSORIES Back to Search Results
Catalog Number 9770501R
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
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 reported issue of delayed ultrasound imaging was confirmed by the service facility and through video attached from the complainant. The site-rite 8 scanner was returned to the service facility for evaluation, however the root cause could not be determined. The service facility re-imaged the scanner as a precaution due to the delay in the image. The system was tested for functionality prior to returning equipment to customer. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
Per tm - sr8 unit has a noticeable delay in scanning. Using filter 3 and software version 1. 0. 3. The delay went away for a short while after re-updating software to 1. 0. 3, but it returned. 08/29/2017-video shows clinician demonstration of us video delay when probe moved.
 
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
Per tm - sr8 unit has a noticeable delay in scanning. Using filter 3 and software version 1. 0. 3. The delay went away for a short while after re-updating software to 1. 0. 3, but it returned. On 08/29/2017-video shows clinician demonstration of us video delay when probe moved.
 
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Brand NameREFURB, SITE-RITE 8
Type of DeviceULTRASOUND AND ACCESSORIES
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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key6863024
MDR Text Key194062797
Report Number3006260740-2017-01584
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152554
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 Received09/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9770501R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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