BASE SYS BI70002000 O-ARM SYS O2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for BASE SYS BI70002000 O-ARM SYS O2 manufactured by Sanmina -sci Systems.

Event Text Entries

[185002565] No patient involved. Other relevant device(s) are: product id: bi71000556, serial/lot#: unknown. Onsite functional and visual examination was performed by a manufacturer representative. Hardware parts were replaced and the issue was resolved. The system passed a system checkout and was returned to an operational condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185002566] Medtronic received information regarding an imaging system used outside of procedure. It was reported that the pendant is not swiveling easily. No patient present.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006544299-2020-00096
MDR Report Key9871155
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-09-05
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1SANMINA -SCI SYSTEMS
Manufacturer StreetKM 15.5 NO. 29, PLANT 06
Manufacturer CityCARR. CHAPALA-GUADALAJARA,JAL 45640
Manufacturer CountryMX
Manufacturer Postal Code45640
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBASE SYS BI70002000 O-ARM SYS O2
Generic NameINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Product CodeOWB
Date Received2020-03-24
Model NumberBI70002000
Catalog NumberBI70002000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSANMINA -SCI SYSTEMS
Manufacturer AddressKM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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