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

Model Number 11007641

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting 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.

Event Description

Siemens became aware of an issue with the sensis vibe hemo system.During an emergency patient procedure, the ecg signal was lost.The user attempted to replace electrodes, lead wires, and trunk cable as well disconnecting and reconnecting the hisib.The patient was moved to an alternate system to complete the procedure.There are no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

Siemens healthineers completed the investigation of the reported event.The investigation was performed based on expert discussions, consideration of the complaint description, customer service reports, system history, and system log files.It was initially reported that there was a loss of ecg vital sign during an emergency case.The log file investigation revealed that the patient was examined for 1.5 hours with unavailable ecg.Further clarification showed that the patient was connected to a second portable monitoring system that monitors ecg, spo2, nibp and etco2 from the beginning.Therefore, the user was able to see the ecg the whole time, including during the relocation time.The reason why the patient was relocated is that the user rebooted the system for troubleshooting reasons and when the system was coming up, auto-login was not enabled for unknown reason.The user did not know the password and therefore relocated the patient to another room.The procedure was finished without any further issues on the other system.No patient health consequences were communicated.Detailed investigation revealed that the cause of the ecg disappearing is that ecg signal drifting outside of the dynamic range of the sensis system.Among the various causes of the ecg signal drifting out of the dynamic range, the most reasonable cause for this case, according to experts, is that the problem was caused by poor contact between the electrode and the skin.It is likely that reapplying/pressing the electrodes to the patient would have reduced the offsets and an ecg would have been available.The system instruction for use gives adequate guidance on proper ecg electrode handling, ecg acquisition techniques and correct lead placement.Furthermore, it was recommended to always have the auto-login enabled.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.The incident described was not classified as a reportable 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.The corresponding probability according to the risk analysis is in the range of "inconceivable".This complaint remains classified as a product problem.The complaint has been closed.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16816069
• MDR Text Key: 314018671
• Report Number: 3004977335-2023-71660
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1