MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM SPECTRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10837643

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 01/15/2019

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.This event occurred in (b)(6).Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom spectra system.During a procedure, a patient with liver metastasis began to deteriorate and went into cardiac arrest.The attending physicians pressed the erdu button and started resuscitation efforts.It was reported that the patient passed away.Siemens has requested additional information in order to conduct an investigation of the reported events.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The complete investigation does not indicate a system failure or malfunction and no non-conformity was identified.The cause of the patient death was due to complications from cancer and not in relation to the siemens product.The death report indicated that the patient death was the result of "neoplasm".Due to poland local regulations, the death report could not be provided to siemens.Review of the qa reports before and after the incident indicate the system was operating within specification and no system malfunction occurred.Additionally, siemens healthineers shenzhen clinical experts reviewed the patient's dicom images.The patient was in a very critical condition.The patient's primary lesion was very large in size and metastatic lesions were found in both the abdomen and thorax.As a result, the patient's diaphragm was moved up in such a way that the heart and lungs were severely pressed and the blood vessels distorted.No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the affected component.

• Brand Name: MAGNETOM SPECTRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• MDR Report Key: 8482548
• MDR Text Key: 140908182
• Report Number: 3004754211-2019-64920
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K153447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10837643
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Weight: 65