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

Model Number	11007641
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.During a procedure, the user reported that no ecg tracing was being displayed.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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.Despite intensive efforts to clarify this incident, the cause of the problem could not be determined beyond doubt as the customer did not report the incident until months after it occurred.The issue occurred on the 01/29/2021, however, siemens was not informed until 4/20/2021.Neither exchanged parts nor logs were available for investigation.Therefore, the outcome of this investigation is mainly based on expert opinion.Based on the description of the issue, expert opinion is that the root cause is the ecg signal was drifting outside of the dynamic range of the hemo integrated signal input box (hisib).The most probable factor for this is the users workflow handling.If the user is not following proper skin-prep and ecg acquisition techniques, the signal may be out of range.If the electrodes are not securely adhered to the skin, a poor connection point is created resulting in high electrode offsets.Proper ecg electrode handling, ecg acquisition techniques and correct lead placement is described in detail in the sensis vibe operator manual and further outlined in the sensis vibe procedure guide.Additionally the "how to improve ecg signal acquisition" guide was released.This guide has been given to the local service organization in order to forward it to the customer, which may give further hints on how to improve the ecg quality.All electrodes were exchanged with a new patch of electrodes.No issues have been reported since a system reboot and following the above mentioned instructions.A possible general error, which would require corrective action of the installed base, could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: SENSIS VIBE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11730823
• Report Number: 3004977335-2021-77460
• Device Sequence Number: 11720726
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1