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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM SENSIS HEMO LOW COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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SIEMENS HEALTHCARE GMBH AXIOM SENSIS HEMO LOW COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 6634633
Device Problem Use of Device Problem (1670)
Patient Problem Death (1802)
Event Date 12/12/2019
Event Type  Death  
Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
 
Event Description
It was reported to siemens that a malfunction and subsequent adverse event occurred while operating the axiom sensis hemo low system. The user reported that the dialog monitor computer (dmc) froze during a patient angioplasty for approximately 7 to 8 minutes. The system restarted itself and the examination was continued. It was later reported that the patient passed away. The cause of the patient death is unknown currently. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameAXIOM SENSIS HEMO LOW
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemensstrasse 1
forccheim, germany 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemensstrasse 1
forccheim, germany 91301
GM 91301
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, pa, PA 19355
6104486461
MDR Report Key9494777
MDR Text Key171976761
Report Number3004977335-2019-11693
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K150493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6634633
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/19/2019 Patient Sequence Number: 1
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