MAUDE Adverse Event Report: SOMATOM X.CITE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 11330001

Device Problem Use of Device Problem (1670)

Patient Problem Bruise/Contusion (1754)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

Reporting facility phone number is: (b)(6).Siemens has initiated a technical investigation of the reported event.The facility staff was reminded to use patient straps prior to use.A root cause has not been identified.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was initially reported to siemens that the patient sustained a large skin tear and bruising on the upper arm during an examination with the somatom x.Cite system.Additional reported information from the facility radiologist and nurse, stated that the patient was treated only with icepacks and panadol for pain.The patient's health status was returned to the level it was before the incident.Therefore, it is unlikely the patient sustained an open skin tear wound, since such an injury would require additional treatment.The patient injury occurred while laying prone on the patient table when their upper arm was caught in the table runner during removal from the gantry.No straps were used to secure the patient during the examination.The reported event occurred in (b)(6).

Manufacturer Narrative

Siemens has completed the investigation of the reported event.The gap between the phs support and phs table was measured onsite and is 5.6mm.This measurement complies with the applicable technical standard which is <8mm.No design issue has been identified.The complainant has been reminded to follow the instructions for use (safety information, chapter 2.4.7, print no.C2-060a-g.621.01.02.02).The user needs to ensure that nothing can get caught while the table or gantry are moving.Furthermore, an arm support accessory is available (see also ifu, chapter 4.1.11).In conclusion, this event was determined to be caused by use error.The patient was not fixated during the examination.No further investigation is warranted at this time.

• Brand Name: SOMATOM X.CITE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11691249
• MDR Text Key: 246231572
• Report Number: 3004977335-2021-74126
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 04056869231044
• UDI-Public: 04056869231044
• Combination Product (y/n): N
• PMA/PMN Number: K200524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11330001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/04/2021
• 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