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

Model Number	10764561
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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 system.During an emergency procedure, the user reported that they were unable to detect pressures.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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation showed that the problem was most likely due to a temporary fault in the pressure line.Unfortunately, this can no longer be confirmed beyond doubt, as parts were replaced on site and the error situation is no longer present.Further investigations on site are no longer possible.Regarding the pressure line and the accessory material not supplied by siemens healthineers, such as the catheter transducer system or the cannulas, new material is used for each patient.In addition, the only questionable part of our system, namely the hemo board pc1308, was replaced as a precaution.The examination by the manufacturer did not reveal any defect, which supports the above hypothesis of a temporary malfunction of the pressure line in the accessories.Nevertheless, the potentially affected parts have been exchanged by the local service organization and the error has not been reported again.The examination of the log files did not point to a product defect.The components and accessories in question were replaced and the system works as specified.A possible general error that would require corrective action of the installed base could not be determined by the investigation.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
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11752554
• Report Number: 3004977335-2021-76353
• Device Sequence Number: 3192541
• Product Code: DQK
• UDI-Device Identifier: 04056869010137
• UDI-Public: 04056869010137
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 10764561
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1