Sensis Vibe Combo 11007642Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056869010205), received between Apr 25, 2022 and Sep 4, 2026 — classified as 1 death, 5 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (1 report).

4 FDA recall records name this device's identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 16, 2022Class IIOpen, Classified

   The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

   Z-0775-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Jul 12, 2022Class IIITerminated

   The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box

   Z-1558-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 15, 2022Class IIOpen, Classified

   Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.

   Z-1426-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. Nov 23, 2021Class IIOpen, Classified

   Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

   Z-0499-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026No Visual Prompts/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610844 ↗
• MalfunctionMay 20, 2025Unexpected Shutdown; Unexpected Shutdown

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SENSIS VIBE COMBO. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SYSTEM FROZE DURING THE PROCEDURE AND AN INJURY WAS COMMUNICATED. THE PROCEDURE WAS CONTINUED USING THE SAME SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052730 ↗
• MalfunctionApr 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATION THE SENSIS VIBE COMBO UNIT. DURING AN INTERVENTIONAL PROCEDURE, THE USER NOTICED THAT THE HEART RATE DISPLAYED BY THE SYSTEM WAS HIGHER THAN THE RATE DISPLAYED ON THE ANESTHESIA MONITOR. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19168450 ↗
• MalfunctionAug 28, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  SIEMENS BECAME AWARE ON A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SENSIS VIBE COMBO SYSTEM. THE USER REPORTED THAT WHILE PERFORMING AN EXTERNAL PACING PROCEDURE, THE SYSTEM STOPPED DISPLAYING VITAL SIGNS AND THE SCREEN WENT BLACK. THE VITAL SIGNS HAD TO MONITORED VIA THE PACEMAKER. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PERSONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630948 ↗
• DeathJul 28, 2022Output Problem; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE BLOOD PRESSURE MEASUREMENT VIA BLOOD PRESSURE CUFF (NBP*) WAS NOT AVAILABLE. ACCORDING TO THE CARDIOLOGISTS, THE PATIENT HAD AN AORTIC RUPTURE AT THE END OF THE EXAMINATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT PASSED AWAY, HOWEVER, THE EXACT CAUSE OF DEATH IS UNKNOWN; AND NO RELATIONSHIP BETWEEN THE OCCURRENCE AND A SYSTEM MALFUNCTION WAS ESTABLISHED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE REPORTED EVENT OCCURRED IN GERMANY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15122165 ↗
• MalfunctionApr 25, 2022No Device Output; No Device Output

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191929 ↗