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

Model Number	10764561
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).
Event or Problem Description
It was reported to siemens that during a schedule diagnostic procedure on the sensis unit the user was unable to balance the pressures.The user made several attempts to balance the pressures unsuccessfully, and the patient had to be moved to another room to complete the exam on alternate system.At this time, siemens has no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The detailed investigation showed that the error was due to a hardware failure.The pc1308a hemo board of the main computer was defective, which meant that the customer was able to see the vital signs; but received error messages regarding the measurement of blood pressure.Multiple reboots and balancing attempts by the customer were unsuccessful.Such an error can only be corrected by an appropriate service call.The regional technical department replaced the corresponding pc board and the system ran again as specified.The spare parts consumption of the affected component was checked.No abnormalities were found and a possible general fault that would require corrective measures 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: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10924575
• Report Number: 3004977335-2020-56715
• Device Sequence Number: 11002809
• Product Code: DQK
• UDI-Device Identifier: 04056869010137
• UDI-Public: 04056869010137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: 11/20/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other