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

Model Number	11007641
Medical Device Problem Codes	Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens conducted a retrospective review and re-evaluated this complaint.Siemens has now deemed that this complaint now meets the requirement for reporting under 21 cfr 803.The investigation was performed considering complaint description, cs reports, system history, and system log files.Logfiles show that the system was rebooted multiple times during that day.It can be seen in the logfiles that import dictionary failed during start of the examination.The patient was registered but the examination did not begin because of the failure in importing the dictionary.This issue is sporadic.When the customer rebooted the system, the system was operating normally and the study could be opened.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.During an emergency procedure, the user reported that examination was not possible after patient registration.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.

• Brand Name: SENSIS VIBE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany ; GM
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17388015
• Report Number: 3004977335-2023-46944
• Device Sequence Number: 14973257
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Repair
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown