MAUDE Adverse Event Report: SIEMENS HEALTHINEERS GMBH SOMATOM SENSATION CARDIAC; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8377520

Device Problems Misconnection (1399); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation by siemens is on-going and a supplemental report will be submitted upon completion should further information become available.

Event Description

It was reported to siemens on (b)(6) 2018 that a malfunction occurred while operating a somatom sensation 64 cardiac system.During a patient procedure, the strap that is used to secure the patient on the table got detached from the table top rail, and the patient almost fell off of the table.We are aware of the patient status: there was no negative impact reported, no injury to the patient.This event occurred in the united states.

Manufacturer Narrative

H10: siemens completed the technical investigation of the reported event.The patient table was delivered to the customer during november 2006 and therefore, has been in use over a period of 12 years.The investigation of the complained table-top shows that the right guiding profile for the patient straps loosened and there is damage to the laminated front side of the table-top.Furthermore, indications of collision on the guiding profile were observed.It was concluded that the breakage of the adhesive connection (guiding profile to table-top) is the result of one or more collisions with unknown devices.The usage of this table-top over a 12-year period without any quality issues is evidence that there is no manufacturing or material defect.The breakage is the result of improper handling.H11: corrected data g5: 510(k) was corrected.

• Brand Name: SOMATOM SENSATION CARDIAC
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; advanced therapy; roentgenstrasse 19-21; kemnath, 95478 ; GM 95478
• MDR Report Key: 7527434
• MDR Text Key: 108754384
• Report Number: 3004977335-2018-27074
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• PMA/PMN Number: K142955
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8377520
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2018
• Distributor Facility Aware Date: 04/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2018
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1