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 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); 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 SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770600Y
Device Problems Battery Problem (2885); Charging Problem (2892)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not been received, at this time.
 
Event Description
Per picc rn - ultrasound is not holding a charge for very long.I tested this morning in my office and the following happened: 100% charge at 9am 89% at 9:25am 60% at 9:55 am shut off at 10am.
 
Event Description
Per picc rn - ultrasound is not holding a charge for very long.I tested this morning in my office and the following happened: 100% charge at 9am 89% at 9:25am 60% at 9:55 am shut off at 10am.
 
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 unit not holding a charge was confirmed.During inspection the scanner was fully charged when the ac adaptor was removed the unit ran for forty minutes and shut off, the cause of the reported issue is due to an internal failure in the lithium-ion battery.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per picc rn - ultrasound is not holding a charge for very long.I tested this morning in my office and the following happened: 100% charge at 9am 89% at 9:25am 60% at 9:55 am shut off at 10am.
 
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 unit not holding a charge was confirmed.During inspection the scanner was fully charged when the ac adaptor was removed the unit ran for forty minutes and shut off, the cause of the reported issue is due to an internal failure in the lithium-ion battery.The device was serviced, tested and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
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 Key8677164
MDR Text Key147449364
Report Number3006260740-2019-01585
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741138287
UDI-Public(01)00801741138287
Combination Product (y/n)N
PMA/PMN Number
K152554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9770600Y
Device Catalogue Number9770600Y
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Event Location Hospital
Initial Date Manufacturer Received 05/20/2019
Initial Date FDA Received06/06/2019
Supplement Dates Manufacturer Received09/13/2019
10/11/2019
Supplement Dates FDA Received10/03/2019
11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2243072-10/11/2019-013-C
Patient Sequence Number1
-
-