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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT SENSIS VIBE COMBO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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SIEMENS HEALTHCARE GMBH-AT SENSIS VIBE COMBO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 11007642
Device Problem No Device Output (1435)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2022
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 vibe combo system.During an emergency procedure, the user reported no communication to the signal input box (sib) and no curves on the live screen.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.
 
Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a software error.Prior to system usage, the user was informed about a pending problem by a message:: "check that the signal input box is turned on and all cables are connected.Correct the problem before starting the examination." the procedure was then performed with an alternative system.According to the analysis of the log file and a performed simulation, the following scenario can lead to the error: if the system is in normal operating mode and then not used for a few hours, it will shut down.The next time the system is used, a communication error may occur sporadically after approximately 10 minutes.The only way to restore system function is to perform an additional system restart.A more detailed analysis revealed that two bios settings causing this error: 1) the operating system setting is set to "linux" instead of "windows".With the introduction of win10, the isib does not shutdown properly with this incorrect setting.2) power saving options are enabled which allow the cpu to turn off when idle.It is planned to resolve those issues with vd12a patch 3.2 which has a planned release date in q3 2022.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.
 
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Brand Name
SENSIS VIBE COMBO
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH-AT
siemensstr. 1
forchheim, germany 91301
GM  91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH-AT
siemensstr. 1
forchheim, germany 91301
GM   91301
Manufacturer Contact
meredith adams
40 liberty blvd.
malvern, PA 19355
4843231631
MDR Report Key14191929
MDR Text Key289961211
Report Number3004977335-2022-24858
Device Sequence Number1
Product Code DQK
UDI-Device Identifier04056869010205
UDI-Public04056869010205
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 Foreign,User Facility,Company Representative
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11007642
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/19/2022
Initial Date FDA Received04/25/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received05/31/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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