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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
Catalog Number 9770501
Device Problems Premature Discharge of Battery (1057); Loss of Power (1475); 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 history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per picc team - unit doesn't hold a charge unless the unit is plugged into an outlet.After it is unplugged, with 100% battery, the system turns off after about 1 minute.
 
Manufacturer Narrative
The device has not been received by the manufacturer, at this time, for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
 
Event Description
Per picc team - unit doesn't hold a charge unless the unit is plugged into an outlet.After it is unplugged, with 100% battery, the system turns off after about 1 minute.
 
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Brand Name
SITE-RITE 8 ULTRASOUND
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 Key8947131
MDR Text Key156272872
Report Number3006260740-2019-02540
Device Sequence Number1
Product Code IYO
UDI-Device Identifier00801741099953
UDI-Public(01)00801741099953
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
Report Date 11/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number9770501
Device Lot NumberN/A
Was Device Available for Evaluation? No
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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