MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, CT QT DCU SOMATOM DEFINITION AS; SYSTEM, XRAY, TOMORGRAPHY, COMPUTED

Model Number 08098027

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

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 if necessary.(b)(6).

Event Description

It was reported to siemens that an injury occurred while operating the somatom definition as system.While moving a patient from the phs tabletop, the customer reported the table movements were too fast and the patent's left hand was injured.The skin on the back of the patient left hand was wounded and required stitches.No further details are known of the state of health of the patient involved.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, XRAY, TOMORGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, CT QT DCU; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, CT QT DCU; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5893248
• MDR Text Key: 52651396
• Report Number: 2240869-2016-04730
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 08098027
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR