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

Model Number 11007641

Device Problem Patient Data Problem (3197)

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

Event Date 04/15/2021

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.The user reported that patient data from a previous case was showing in the most recent case on the patient explorer.At this time, we are unaware of any impact to the state of health of any patient or user 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 software error.The detailed investigation showed that the problem was not an error in the generation of x-ray images, but a problem in the creation of reports, which only takes place after the examination.This could be proven by examining the log files.Furthermore, it does not affect all studies in general, but the error only occurs when two studies of the same patient have been made.In this case, both studies of the same patient are linked, because they have the same sequence number field (segno field).A possible mixing of data of different patients is not possible.The workaround step is to manually update the study segno field for this study record to the next value so that the study link to the study data will be established correctly.In this case, the segno field of both studies has already been corrected.A possible general error, which would require corrective measures of the installed base, could not be determined by the investigation.For future software versions, this rare effect will be taken into account accordingly.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; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11775886
• MDR Text Key: 248994987
• Report Number: 3004977335-2021-77192
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• 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,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

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
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1