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

Model Number 10046733

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(6).(b)(4) (importer) is submitting the report on behalf of siemens (b)(4) (manufacturer).Based on current information provided, the operator did not instruct the patient in regard to safety measures during intervention and table movement however the customer was advised to inform every patient going forward.A detailed investigation of the table has been initiated and is ongoing.A supplemental report will be submitted if further information becomes available.

Event Description

Siemens was informed on (b)(6) 2017 that after a ct examination was finished, the patient lowered their arms and grabbed the table between the table top and table stand.In doing so, the patient's finger was cut during table unload movement.It was reported that the patient was sent to the emergency room where the patient received four stitches to treat the wound.There is no further information regarding the patient's status at this time.This reported issue occurred in (b)(6).

Manufacturer Narrative

Exemption number e2017017.Siemens healthineers malvern usa (importer) is submitting the report on behalf of siemens gmbh, (b)(4) (manufacturer).Device manufacture date - information provided.Measurements of the gaps between table top and table support were as specified.The patient's injury was caused by the user's error of incorrect/insufficient patient fixation according to user manual.Considering this.No further corrective action is initiated.

• Brand Name: SOMATOM PERSPECTIVE
• 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: 6731523
• MDR Text Key: 80661648
• Report Number: 3004977335-2017-85498
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K113287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2017,06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10046733
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2017
• Distributor Facility Aware Date: 06/23/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2017
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2013
• 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
• Treatment: PATIENT TABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70