Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 6 SCANNER; 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 6 SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Catalog Number 9770066
Device Problems Battery Problem (2885); Power Problem (3010)
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.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.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 the chief nurse that the site rite 6 ultrasound system is shutting down without command mid-procedures even when connected to ac power.The battery status is known when system shuts down.
 
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 system is shutting down without command mid-procedures even when connected to ac power was unconfirmed.The scanner powers on and boots up normally.The scanner was powered on and initialized and ran uninterrupted for 2 hours.The scanner was evaluated and no malfunctions were found.The error log was checked and is empty of any errors related to the problem.The device was serviced, tested and returned to customer.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
 
Event Description
It was reported by the chief nurse that the site rite 6 ultrasound system is shutting down without command mid-procedures even when connected to ac power.The battery status is known when system shuts down.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SITE -RITE 6 SCANNER
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 Key7768430
MDR Text Key116902171
Report Number3006260740-2018-01999
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741091049
UDI-Public(01)00801741091049
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 05/21/2019
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 Catalogue Number9770066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Event Location Hospital
Date Manufacturer Received05/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-