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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
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BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 9770600Y
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Intermittent Loss of Power (4016)
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 nurse, the battery won't hold a charge, battery wont last longer than 50%.Periodically shuts off.Each time the ultrasound has shut off, the second picc nurse will plug-in and restart.
 
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 the battery will not hold a charge is confirmed.The scanner shuts down prematurely after ac power is removed.The root cause of the reported issue is a n internal li-ion battery failure.No other functionality issues with the equipment were found during evaluation/servicing.The device was service, 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 nurse, the battery won't hold a charge, battery wont last longer than 50%.Periodically shuts off.Each time the ultrasound has shut off, the second picc nurse will plug-in and restart.
 
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 the battery will not hold a charge is confirmed.The scanner shuts down prematurely after ac power is removed.The root cause of the reported issue is a n internal li-ion battery failure.No other functionality issues with the equipment were found during evaluation/servicing.The device was service, 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 nurse, the battery won't hold a charge, battery wont last longer than 50%.Periodically shuts off.Each time the ultrasound has shut off, the second picc nurse will plug-in and restart.
 
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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 Key8717249
MDR Text Key148818571
Report Number3006260740-2019-01693
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
Date FDA Received06/20/2019
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 Manufacturer06/26/2019
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
Patient Sequence Number1
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