MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM EMOTION 16 (2007); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 1025253055

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Siemen's investigated the reported incident.The root causes are identified as failure of the customer to repair the damaged table before use during patient treatment and not properly fixating the patient's arm during treatment.The reported device did not malfunction.A supplemental report will be submitted if additional reportable information is received.

Event Description

It was reported to siemens that during use of the somatom emotion 16 (2007) a moderate patient injury occurred.The patient's finger was caught between the system table and gantry cover and the patient's skin was lacerated by the sharp edges of the previously damaged table cover.The wound was treated during a brief medical intervention to stop the bleeding.There is no permanent injury expected due to the event.The table cover was reportedly damaged before the reported event.The event is not associated with an identified device malfunction.The source of the table damage was not reported by the customer, nor was siemens notified to repair it before the patient event.The strap used to fixate patient's arms became loose and the patient's arm slipped into the gap between the damaged table and the gantry while the table was moved into the gantry.The reported event occurred in (b)(6).

• Brand Name: SOMATOM EMOTION 16 (2007)
• 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; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486484
• MDR Report Key: 8975837
• MDR Text Key: 161093990
• Report Number: 3004977335-2019-95923
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K050297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1025253055
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention