FIXED IMAGING EQUIPMENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for FIXED IMAGING EQUIPMENT manufactured by Siemens Medical Solutions Usa, Inc..

Event Text Entries

[182352728] Siemens imaging system error identified prior to placing patient on table for procedure. Engineering determined that siemens representative needed to diagnose and troubleshoot computer hardware problem. Patient moved back to holding area with plan to wait and see if it gets fixed and reschedule otherwise. Lack of alternative hybrid room availability likely means that we cannot accept ruptured aneurysms. This is second time this has happened to one of my patients within the last 3 weeks (last patient was anesthetized when the issue was identified), and therefore should be viewed as a pattern rather than an isolated event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9798446
MDR Report Key9798446
Date Received2020-03-06
Date of Report2019-12-06
Date of Event2019-07-02
Report Date2019-12-09
Date Reported to FDA2019-12-09
Date Reported to Mfgr2020-03-06
Date Added to Maude2020-03-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFIXED IMAGING EQUIPMENT
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product CodeJAA
Date Received2020-03-06
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS MEDICAL SOLUTIONS USA, INC.
Manufacturer Address40 LIBERTY BOULEVARD MAILCODE: 65-1A MALVERN PA 19355 US 19355


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-06

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