MAUDE Adverse Event Report: SIEMENS HEALTHINEERS GMBH SOMATOM SENSATION 16; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 07393114

Device Problems Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ct system's user manual instructs that the patient / patient arms must be secured to avoid collision with the gantry.Furthermore, the patient must be monitored during table movement.As the patient was not secured with the provided belts, this event is deemed as use error.The system has been repair and is in working order.Considering this, no further corrective action is initiated.(b)(6).

Event Description

On (b)(6) 2017 siemens became aware that on the same day a patient was injured during a ct scan.According to information received from the customer service engineer and customer confirmation, the patient's elbow was injured with scratches and light lacerations.The patient was on the table in the gantry when they touched the plexiring with their elbow.The plexiring broke and is what caused the patient's injury.(b)(6).

• Brand Name: SOMATOM SENSATION 16
• 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: 6855780
• MDR Text Key: 85734759
• Report Number: 3004977335-2017-04528
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142955
• 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
• Report Date: 09/08/2017,08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 07393114
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2017
• Distributor Facility Aware Date: 08/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2017
• Date Manufacturer Received: 08/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention