MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM FORCE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10742326
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/12/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Reporting facility telephone number is: (b)(6).Siemens has initiated a technical investigation of the reported event.Please note, that although the event reportedly did not contribute to the death of the infant patient, siemens is reporting this incident as an adverse event with respect to the additional contrast needed due to the system abort.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction of the somatom force system occurred during the performance of a cardiac scan on a newborn infant (1 day old).The pre-monitoring & monitoring scans were completed and while the user was observing the delay period to allow the contrast to be administered for the bolus monitoring, the scan did not commence and as a result, the system needed to be restarted.The scan continued after the system reboot, but this inadvertently caused a delay resulting in the necessity for additional contrast to be administered.The only negative impact of this event was the necessity for additional contrast media due to the delay caused by the time needed to reboot the system.The radiographer indicated that there was no adverse impact to the patient from the additional contrast.According to the hospital, the infant unfortunately died due to cardiac failure associated with a birth defect.The infant's death was not associated with the reported incident.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Siemens completed the technical investigation of the reported incident.The root cause of the scan abort was due to the extreme heartrates of the infant patient in combination with an ecg triggered flash scan.In the beginning of the examination, the heartrates were extremely fast and unsteady.The rpeaks were 200ms and 600ms (100-300bm).Afterwards, the patient's heart stopped for a short time.The device specification heart rate measurement of pmm has the following accuracy when measured on a periodic technically simulated signal: 30bpm: +/- 1bpm.45bpm: +/- 1bpm.60bpm: +/- 1bpm.75bpm: +/- 1bpm.90bpm: +/- 1bpm.120bpm: +/- 2bpm.150bpm: +/- 3bpm.180bpm: +/- 4bpm.Siemens reviewed the provided system logs associated with the event.In conclusion, no system design issue was identified, and it was determined that the reported medical device system works as specified.The user should not use an ecg triggered flash scan under this special condition.No remedial action is deemed necessary.

• Brand Name: SOMATOM FORCE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 12870019
• Report Number: 3004977335-2021-05302
• Device Sequence Number: 17037091
• Product Code: JAK
• UDI-Device Identifier: 04056869006956
• UDI-Public: 04056869006956
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10742326
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 4 KG