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

Model Number 11007641

Device Problem Failure to Sense (1559)

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

Event Date 12/03/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 285825298
• Report Number: 3004977335-2021-08147
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/02/2022
• 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