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

Model Number 11007642

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/11/2022

Event Type  Death  

Event Description

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.

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.Internal id # (b)(4).

Manufacturer Narrative

Siemens conducted a detailed investigation of the reported event.According to the provided information, blood pressure measurement by means of a blood pressure cuff (nbp) did not work during an emergency case (patient with a heart attack).The following error message was displayed to the user: "nbp value out of range", "the nbp measurement has failed.One or more values (sys, dia, map and hf) are out of range.Please check if there is a serious problem with the patient's blood pressure".The patient had to be resuscitated at that time.After an unknown amount of time, the following message was displayed to the user: "the nbp measurement has failed.The nbp value cannot be measured due to an oscillometric signal that is too weak or not present.Check that the tubing and cuff are the correct size and fit correctly.Restart the nbp measurement" according to the physician's information, the patient died of the heart attack and an aortic rupture.From both a technical and medical perspective, the system behavior can be explained.The system reacted according to the patient's condition.In case of cardiac arrest, blood pressure cannot be measured, and the system displays above messages to the user.According to logs no failure was present at the sensis system.The system worked as specified.The sensis device did not cause nor contribute to the patient's death.The incident described in the adverse event is not classified as a reportable event after a thorough investigation because no malfunction of the system could be detected.Internal id# (b)(4).

• Brand Name: SENSIS VIBE COMBO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - AT; siemensstr. 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15122165
• MDR Text Key: 296780676
• Report Number: 3004977335-2022-37557
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11007642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Male