MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SENSIS VIBE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	11007641
Medical Device Problem Codes	No Display/Image (1183); No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the sensis vibe hemo system.Prior to an emergency patient procedure, there was no display output.The failure caused a long-term delay of the emergency procedure.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation was completed by our experts.The on-site service intervention identified a loose video adapter cable.Neither a defect in the cable nor why or how the cable became loose could be determined.As a preventive measure, the cable was replaced by siemens local service.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
Additional Manufacturer Narrative
Purpose of this supplemental report is to correct section d4 ¿primary udi number¿ per request by the mdr data systems team (cdrh) dated june 11, 2024.The primary udi number now contains the di and pi numbers as requested.

• Brand Name: SENSIS VIBE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18256642
• Report Number: 3004977335-2023-00157
• Device Sequence Number: 6685373
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: (01)04056869010199(21)103632
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 06/27/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/20/2023; 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown