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

Model Number	11007641
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.During a procedure on a patient suffering from a heart attack, no aortic pressure measurement was available to the user.We are unaware of any adverse impact to the state of health of the patient involved.
Additional Manufacturer Narrative
H3, h6: a detailed investigation of the reported event and system was completed.The investigation was performed based on expert discussions considering complaint description, customer service reports, system history and system log files.According to the initially provided information.No internal blood pressure (ibp) function was available during a procedure where the patient had a ¿st-elevation¿ myocardial infarction (stemi).All functions that are not related to internal blood pressure (e.G., ecg were not affected).The procedure was continued and finalized with that system.However, for monitoring ibp function an external monitor was used.No health consequences were reported to this event.The detailed log-file investigation confirmed that the ibp function was not available as the system did not recognize the pressure transducer during balancing attempts.As a result, the following error message was displayed to the user: "detected disconnected pressure transducers.The transducers must be connected, or their corresponding signals removed from the pressure scheme.The transducers are: p1".The analysis of the system log-files could not determine which hardware exactly which component failed and why the sensor was not recognized.To resolve the problem, the ibp adapter cable and the ¿hisib¿-system were replaced as part of service activity.The error mentioned in the complaint has not again been reported since then.Unfortunately, further investigation had to be stopped as the replaced parts are not available.The spare part consumption related to the exchanged parts is higher than expected.Therefore, the development of further spare part consumption will be closely monitored and investigated.The incident described in the reported event is not classified as a reportable event adverse event after a thorough investigation because neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected, even if the incident recurs.

• Brand Name: SENSIS VIBE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17594950
• Report Number: 3004977335-2023-00094
• Device Sequence Number: 20511438
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown