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

Model Number 10430603

Device Problem Unintended Collision (1429)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported to siemens that during a patient procedure, the tabletop of the phs (patient handling system) touched the ct gantry cover while pressing the unload button.Neither the patient nor the user was injured during the event.According to the siemens r&d expert, in a worst-case scenario, a crushing-type injury to the patient or user cannot be excluded in the case of a re-occurrence.The collision detection system did not stop the table motion before the collision.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens has initiated a technical investigation of the issue to identify the root cause.A siemens field service engineer replaced the patient table motor controller and the encoder.A technical investigation of the replaced parts will commence as soon as the parts are received by siemens for analysis.A supplemental report will be filed upon completion of the investigation.

Manufacturer Narrative

Siemens has initiated a technical investigation of the issue to identify the root cause.A siemens field service engineer replaced the patient table motor controller and the encoder.A technical investigation of the replaced parts will commence as soon as the parts are received by siemens for analysis.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that during a patient procedure, the tabletop of the phs (patient handling system) touched the ct gantry cover while pressing the unload button.Neither the patient nor the user was injured during the event.According to the siemens r&d expert, in a worst-case scenario, a crushing-type injury to the patient or user cannot be excluded in the case of a re-occurrence.The collision detection system did not stop the table motion before the collision.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens performed a detailed technical investigation of the reported event.The returned complaint parts, rot.Encoder - vertical, part number 8675311 and the motor controller - vertical - part number 8673530, were tested at siemens internal supplier of the patient table.Independent and combination tests were performed.The tests performed were comparable to "real" application in the field, with high weights (107 kg and 190 kg) and in simulated unloading cycles (parallel vertical and horizontal movement).After approximately 20,000 cycles under the test conditions, no malfunction was detected.These investigation results indicate that the affected rot.Encoder and motor controller functioned according to specification.However, siemens determined that an additional external investigation by the encoder manufacturer should be performed.The encoder was sent to posital gmbh, carlswerkstrasse 13c, d-51063, köln, germany for further investigation.A second supplemental report will be submitted upon completion of the additional investigation.

Manufacturer Narrative

Siemens has performed a detailed technical investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The replaced encoder and motor controller from the affected system was returned to the component supplier for further investigation.First, the encoder itself was tested in a phs4 (patient table) in combination with a functioning motor controller, with the result that no malfunction was detected.Secondly, the affected encoder and the motor controller were installed in the same phs4 in the laboratory in kemnath (siemens healthineers, germany).The phs (patient table) was run according to the field application with high weights (107kg and 190kg) and in simulated unloading cycle (parallel vertical and horizontal movement).After about 20,000 cycles under test conditions, no malfunction was detected.Finally, the encoder was sent to the supplier (baumer company) and examined for functionality.No malfunction could be detected.The supplier forwarded the inner board of the encoder to his sub-supplier for x-ray analysis.Again, no fault could be identified.The affected encoder and the motor controller are working according to its specification.The escalated system behavior (vertical position was shifted downwards by approx.55 mm) could not be reproduced, neither during the intensive technical investigation nor in the installed volume on any other identical system.Since the replacement of the components, no recurrence of the phenomenon has been reported at the complaint system.No remedial action is necessary, as no general design issue has been determined.

• Brand Name: SOMATOM DEFINITION FLASH
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-CT; siemensstr. 1; forchheim, germany PA 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843231631
• MDR Report Key: 13391677
• MDR Text Key: 286020150
• Report Number: 3004977335-2022-13275
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1