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

Model Number 11007641

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 08/30/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).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 an adverse event occurred while operating the sensis vibe hemo diagnostic device during an interventional procedure with the artis zeego system.The user reported difficulty with logging vital signs during a cardiac event.The non-invasive blood pressure values could not be reported in the vital signs event log.The user received an error message and recommendation from the system on how to proceed.It was reported that the patient passed away.The condition of the patient prior to and during the procedure is not known at this time.Additional details have been requested for investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Based on log file analysis and information provided from the customer, the sensis system had no impact on the patient outcome.During the procedure, the real time computer (rtc) displayed all vital signs along with patient waveforms at the monitor.The logs show that several bradycardia and tachycardia were detected multiple times by the system and correctly reported to the users.During the event some non-invasive blood pressure (nipb) measurements, oxygen saturation (spo2) and heart rate (hr) were not logged to file because of a software bug.The failure not to log the vital signs during the event does not result in any patient harm.The vital signs remain visible on the rtc screen throughout the procedure.In addition, logging of the vital signs data will resume when the nibp disturbance (like a kinked measure hose or a loose cuff) is resolved.No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the affected system.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 8482611
• MDR Text Key: 140905187
• Report Number: 3004977335-2018-46772
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2018
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death