MOBILETT XP HYBRID 01818454

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 2019-03-27 for MOBILETT XP HYBRID 01818454 manufactured by Siemens Healthcare Gmbh.

Event Text Entries

[140123203] (b)(4). The power cable on the concerned unit was replaced and the system was returned to use. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[140123204] Siemens was informed about an incident on the mobilett xp hybrid. When the operator plugged the unit system into the wall outlet, a blue spark was seen. There is no patient involvement in this case as the spark occurred when the system batteries were plugged to be charged. The incident occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002808157-2019-73957
MDR Report Key8457839
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-27
Date of Report2019-03-13
Date of Event2019-03-13
Date Facility Aware2019-03-13
Report Date2019-03-13
Date Reported to Mfgr2019-03-13
Date Mfgr Received2019-05-21
Date Added to Maude2019-03-27
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 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 XP HYBRID
Generic NameMOBILE X-RAY SYSTEM
Product CodeIZL
Date Received2019-03-27
Model Number01818454
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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 2019-03-27

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