SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED) 9770600Y

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED) 9770600Y manufactured by Bard Access Systems.

Event Text Entries

[184660238] A replacement battery was sent to the reporting facility. Therefore, the device will not be returned for evaluation. A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Patient Sequence No: 1, Text Type: N, H10


[184660239] Per radiology team the scanner does not hold a charge/abrupt shut off.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2020-00915
MDR Report Key9857195
Report SourceUSER FACILITY
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHELLY GILBERT
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225640
Manufacturer G1DYMAX CORP.
Manufacturer Street141 ZEHNER SCHOOL ROAD
Manufacturer CityZELIENOPLE PA 16063
Manufacturer CountryUS
Manufacturer Postal Code16063
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction Number2243072-10/11/2019-013-C
Event Type3
Type of Report3

Device Details

Brand NameSITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
Generic NameSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Product CodeIYO
Date Received2020-03-19
Model Number9770600Y
Catalog Number9770600Y
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.