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

Model Number 8098027

Device Problems Component or Accessory Incompatibility (2897); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is on-going and a supplemental report will be submitted if further information becomes available.(b)(6).

Event Description

The customer reported to siemens on (b)(6) 2017 that they found the gantry lower front segment was broken during gantry tilt.There is no report of mistreatment or injury to a patient.This reported issue occurred in (b)(6).

Manufacturer Narrative

Investigation of the reported issue revealed that an unauthorized metal cover, made and installed by the customer, was placed over the foot switches at the bottom of the patient table to prevent damage when relatives of the patients enters the scan room prior to patient examination.The customer reported that they have had to replace parts of the table twice before, so they placed the metal cover over foot switches to protect against future damage.The metal cover did not allow enough space during gantry tilt and caused the damage to the gantry cover.The metal cover presents an unauthorized modification to the medical device therefore the reported issue is deemed as use error.Considering this, no further corrective action is initiated.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; 1 siemens strasse; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6789777
• MDR Text Key: 82712100
• Report Number: 3004977335-2017-90850
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/09/2018,08/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8098027
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/09/2018
• Distributor Facility Aware Date: 08/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2018
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1