MOBILETT MIRA MAX 10594738

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-19 for MOBILETT MIRA MAX 10594738 manufactured by Siemens Healthcare Gmbh.

Event Text Entries

[142512854] Resubmission of initial report as per fda on 4/3/2019. Investigation is on-going. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[142512856] Siemens received a video of uncontrolled system movement of the mobilett mira max unit. The circumstances leading to this system behavior were not described and remain unclear. A request for more information was sent to the user. The reported incident occurred in saudi arabia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002808157-2018-62149
MDR Report Key8531620
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-04-19
Date of Event2018-12-19
Date Mfgr Received2019-02-20
Date Added to Maude2019-04-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANASTASIA SOKOLOVA
Manufacturer Street40 LIBERTY BLVD, MC 65-1A
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6104486478
Manufacturer G1SIEMENS HEALTHCARE GMBH
Manufacturer StreetHENKESTRASSE 127
Manufacturer CityERLANGEN, 91052
Manufacturer CountryGM
Manufacturer Postal Code91052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMOBILETT MIRA MAX
Generic NameMOBILE X-RAY SYSTEM
Product CodeIZL
Date Received2019-04-19
Model Number10594738
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH
Manufacturer AddressHENKESTRASSE 127 ERLANGEN, 91052 GM 91052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-19

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