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

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.

• 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 Key: 14191929
• MDR Text Key: 289961211
• Report Number: 3004977335-2022-24858
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010205
• UDI-Public: 04056869010205
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• 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 Number: 11007642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1