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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770500
Device Problems Loss of Power (1475); Battery Problem (2885)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will be evaluated. Results are expected soon. 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 dyasac016 showed no other similar product complaint(s) from this serial number.
 
Event Description
Per rn: the machine shuts down after being plugged in all night around 86% battery life. This is very inconvenient to have the machine turn off in the middle of a procedure.
 
Event Description
Per rn: the machine shuts down after being plugged in all night around 86% battery life. This is very inconvenient to have the machine turn off in the middle of a procedure.
 
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 shutdown abruptly was confirmed. The scanner will shut down after a few minutes unplugged from the power supply. The root cause of the failure was identified as an internal failure in the lithium ion battery. The device was serviced, tested, and returned to the customer. 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 dyasac016 showed no other similar product complaint(s) from this serial number.
 
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Brand NameSITE-RITE 8 ULTRASOUND
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8576138
MDR Text Key144149184
Report Number3006260740-2019-01277
Device Sequence Number1
Product Code IYO
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
0 Patients were Involved in the Event:
Date FDA Received05/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9770500
Device Catalogue Number9770500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
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

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