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

Model Number 7740769

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

Patient Problems Injury (2348); Suture Abrasion (2497)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Siemens conducted a thorough investigation that revealed that the patient table straps were not utilized to secure the patient, as instructed in the user manual.Further investigation showed part of the table cover area was broken, rendering the table not completely operational.The broken table cover parts were replaced, which brought the phs table into specification.Considering this, no further correction is initiated.

Event Description

It was reported to siemens on (b)(6) 2018, that an unconscious (b)(6)-year old female patient was injured while the phs table ( patient table) was being unloaded.One finger of the patient's left hand was squeezed into the gap between the table top and phs side support.The patient's finger was bleeding and required stitches, which was performed by the hospital.There is no information available regarding the patient's status at this time.This event occurred in (b)(6).

• Brand Name: SOMATOM DEFINITION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHINEERS GMBH; advanced therapy; siemenstrasse 1; forchheim,, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS GMBH; siemenstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: mary stamer ; 40 liberty boulevard; ms-65-1a; malvern, PA 19355-9998 ; 6104486485
• MDR Report Key: 7366737
• MDR Text Key: 103398012
• Report Number: 3004977335-2018-18938
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/23/2018,02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7740769
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/23/2018
• Distributor Facility Aware Date: 02/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2018
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 80 YR