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

Model Number 11007641

Device Problem No Visual Prompts/Feedback (4021)

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

Event Date 05/19/2023

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

It was reported to siemens that a malfunction occurred while operating the sensis vibe hemo system.The user reported that at the start of intervention ecg signal was lost.The user tried to replace electrodes and re-start the system.The patient had to be moved to an alternate unit.There is no report of impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens completed the detailed investigation of the reported event and system.The investigation was performed based on expert discussions considering the complaint description, customer service reports, system history, system log file analysis.According to the provided information, there were no ecg signal during an interventional procedure.The procedure was then continued and finished using an alternative system.No health consequences were communicated.Detailed investigations revealed that the reason why no ecg was available was that the ecg signal drifted outside 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 instruction for use gives adequate guidance on proper ecg electrode handling, ecg acquisition techniques and correct lead placement.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.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstrasse 1 or; rittigfeld 1; forchheim 93101 ; GM 93101
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16991959
• MDR Text Key: 316291604
• Report Number: 3004977335-2023-00029
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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: 05/19/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1