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

Model Number 8098027

Device Problem Human-Device Interface Problem (2949)

Patient Problem Bruise/Contusion (1754)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

Based on available information and pictures received, the table was within specification.Due to the patient being handicapped with an immovable arm, the root cause is seen as use error because the pantient's arm was not fixed with a belt, as it is recommended for patients in the user manual.Considering this, no corrective action is initiated.

Event Description

It was reported to siemens on (b)(6) 2017 that a (b)(6) female hemiplegic patient was injured when being moved out of the gantry after a lung examination.The patients arm is immovable and was not strapped in place by use of the belts on the patient table.The patient's skin on their arm became clamped in the gap of the table.The patient was given emergency treatment however an x-ray showed there was no broken bone, only the skin and muscle are red and swollen.Patient status is unknown at this time.

• Brand Name: SOMATOM DEFINITION AS
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; siemens strasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: marlynne galloway ; 40 liberty boulevard; mc: 65-1a; malvern, PA 19355-9998 ; 6104486471
• MDR Report Key: 6888452
• MDR Text Key: 87206709
• Report Number: 3004977335-2017-93700
• 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: Other
• Type of Report: Initial
• Report Date: 09/25/2017,08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8098027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2017
• Distributor Facility Aware Date: 08/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2017
• Date Manufacturer Received: 08/28/2017
• 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
• Patient Age: 90 YR