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

Model Number	11007641
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
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 an interventional procedure, the user reported that the limb leads flat line when the v leads are connected.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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a user workflow error.The investigation was performed considering complaint description, cs reports, system history, and system log files.According to customer information, good ecg signals on the limb leads were present.The customer attempted to connect additional chest leads resulting in ecg flatlines.When the chest leads were disconnected, the limb leads were displayed normally.The patient was relocated to another room where the same behavior was observed.The customer then monitored the chest leads on an external monitor to finish the study.From the analysis of the log files, it was determined that the ecg signal was outside the dynamic range of the integrated hemo signal input box (hisib).Furthermore, it could be seen that some electrodes had offsets but did not run into lead-off detection because the sum of the offsets were not exceeding the lead-off threshold.Adding one additional electrode (chest electrodes) caused even more offset, which resulted in the ecg signal disappearence.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 the sensis vibe operator manual (axa5-200.620.09.Xx.Xx) and outlined in the sensis vibe procedure guide (axa5-200.622.13.01.02).Additionally the "how to improve ecg signal acquisition" (axa5-200.640.21.01.02) guide was released and has been provided to the customer.No further issues have been reported since.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-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 13042120
• Report Number: 3004977335-2021-08147
• Device Sequence Number: 5448985
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown