• 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 Loss of Power (1475); Battery Problem (2885)
Patient Problems No Consequences Or Impact To Patient (2199); 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 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.
 
Event Description
Customer reported unit shuts down when the battery is still at 80%.
 
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 abrupt shutdown during use was confirmed. The scanner was charged to 100% and when the ac adapter was removed, the scanner ran on battery power for less than 5 minutes. The root cause of the shutdown during use was identified as a failure in the lithium-ion battery. 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. No other issues with the equipment were found during evaluation. The sr8 was serviced, qc tested, and returned to the customer.
 
Event Description
Customer reported unit shuts down when the battery is still at 80%.
 
Event Description
Customer reported unit shuts down when the battery is still at 80%.
 
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 abrupt shutdown during use was confirmed. The scanner was charged to 100% and when the ac adapter was removed, the scanner ran on battery power for less than 5 minutes. The root cause of the shutdown during use was identified as a failure in the lithium-ion battery. 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. No other issues with the equipment were found during evaluation. The sr8 was serviced, qc tested, and returned to the customer.
 
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
MDR Report Key7435098
MDR Text Key105769791
Report Number3006260740-2018-00718
Device Sequence Number1
Product Code ITX
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 11/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770501
Device Catalogue Number9770501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2018
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2243072-10/11/2019-013-C

-
-