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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH- AT SENSIS HEMO LOW COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 6634633
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/11/2020
Event Type  malfunction  
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 occurred while operating the sensis hemo low system. During an interventional procedure, the user reported that a heart rate value of 0 was displayed. The procedure was continued and completed on an alternate system. We are unaware of any impact to the state of health of the patient involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameSENSIS HEMO LOW
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH- AT
siemensstrasse 1
forchheim, germany 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH- AT
siemensstrasse 1
forchheim, germany 91301
GM 91301
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, PA 19355
6104486461
MDR Report Key10586129
MDR Text Key213682449
Report Number3004977335-2020-47098
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 09/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received11/10/2020
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

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