PRECISION 500D R&F X-RAY SYSTEM 2290800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-22 for PRECISION 500D R&F X-RAY SYSTEM 2290800 manufactured by Ge Medical Systems, Llc.

Event Text Entries

[145779682] A ge healthcare investigation has been initiated and is ongoing. A follow-up mdr will be provided when ge healthcare's investigation has been completed. Although requested, the user was unable to provide patient information. Although requested, the user was unable to provide the incident date. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10


[145779683] During a periodic maintenance inspection being performed on (b)(6) 2019 at riverside healthcare in the united states, the ge field engineer (fe) was notified that a patient had fallen off their precision 500d system¿? S table and was injured. The customer reported that during an exam while waiting for time to elapse to continue with the procedure, the patient had fallen asleep while lying on the table. While they were asleep, they fell from the table and received a broken toe. The customer did not provide any further details of the event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2126677-2019-00005
MDR Report Key8631846
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-22
Date of Report2019-07-03
Date Mfgr Received2019-06-17
Device Manufacturer Date2015-11-02
Date Added to Maude2019-05-22
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 ContactSTEVEN WALCZAK
Manufacturer Street3000 NORTH GRANDVIEW BOULEVARD
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRECISION 500D R&F X-RAY SYSTEM
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
Product CodeJAA
Date Received2019-05-22
Model Number2290800
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3000 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-22

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