• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770501
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 device has not been returned to the manufacturer, at this time, for evaluation. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
Customer reported system freezes and "the back of the machine shows on the ultrasound".
 
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: during evaluation, the reported issue of system freezing could not be reproduced. The scanner was evaluated and was found to function normally. The scanner did not freeze in ultrasound mode and the screen responded to probe and touchscreen input. The back of the machine was not visible on the ultrasound. The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue. See referenced complaint for additional failure modes found during evaluation. The sr8 was serviced, tested, and returned to the customer.
 
Event Description
Customer reported system freezes and "the back of the machine shows on the ultrasound".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSITE-RITE 8 ULTRASOUND SYSTEM W/PINPOINT GT
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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
sydney freckleton
605 n. 5600 w.
salt lake city, UT 84116
8015225992
MDR Report Key7394479
MDR Text Key104428675
Report Number3006260740-2018-00578
Device Sequence Number1
Product Code ITX
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/24/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-