AXIOM ICONOS R200 10093961

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-29 for AXIOM ICONOS R200 10093961 manufactured by Siemens Healthcare Gmbh, Advanced Therapies.

Event Text Entries

[143395696] The system is equipped with safety switches that should stop all system movement in case of collision with foreign object. In the reported case, the applied force to the hand was limited as the cover underneath the table is flexible. When the cover is bent due to the pressure applied by an obstacle, the safety switches should be activated and stop motorized movement immediately. According to the description in the user manual axd3-340. 620. 14 (pages 35 and 53), the operator may release system movements only after ensure that no person is endangered and that the handgrips are properly used. (b)(6). Resubmission of initial report due to report code error.
Patient Sequence No: 1, Text Type: N, H10


[143395697] It was reported that a patient's hand was trapped under the table top on the axiom iconos r200 system. The hand was caught between the spotfilm device and edge of the table. When the hand got trapped, all table movements were disabled and it was hard to move the table to free patient's hand. As a result of the incident, the patient suffered from a puncture wound and a broken bone. An x-ray examination followed the adverse event. The patient received medical treatment at the facility. Further information regarding the treatment was requested. The reported event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004977335-2016-30340
MDR Report Key8560208
Report SourceFOREIGN
Date Received2019-04-29
Date of Report2016-01-12
Date of Event2016-01-11
Date Mfgr Received2016-01-12
Date Added to Maude2019-04-29
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 ContactMEREDITH ADAMS
Manufacturer Street40 LIBERTY BLVD. 65-1A
Manufacturer CityMALVERN PA 19355
Manufacturer CountryUS
Manufacturer Postal19355
Manufacturer Phone6104486461
Manufacturer G1SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES
Manufacturer StreetSIEMENSSTRASSE 1
Manufacturer CityFORCHHEIM, GERMANY 91301
Manufacturer CountryGM
Manufacturer Postal Code91301
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXIOM ICONOS R200
Generic NameSYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Product CodeJAA
Date Received2019-04-29
Model Number10093961
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES
Manufacturer AddressSIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 GM 91301


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-29

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