MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD MULTIX SELECT DR; STATIONARY X-RAY SYSTEM

Model Number 10569624

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation of the event is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

November 26th, 2018 siemens received a letter from a customer in (b)(6) informing of the following incident with the multix select dr x-ray system.According to the letter, during an x-ray examination of the accessory sinuses of the nose, the bucky of the bucky wall stand fell on both legs of a patient.As a result the patient complained of acute pain in her left foot.The x-ray images of the left foot were taken at the emergency room of the (b)(6) hospital.It was determined by a trauma specialist that the patient's left foot first metatarsal had signs of fracture.The patient required plaster immobilization of the foot, which resulted in limited mobility.The reported event occurred in (b)(6).

Manufacturer Narrative

**resubmission of initial report as per fda on 4/3/2019** the investigation of the reported incident was completed with the following results.Siemens local service identified two issues with the unit: the bucky wall stands (bws) switch button was stuck resulting in brake failure; the overhead arm support was installed on the bws; however, the bws was not properly balanced.The two issues described above resulted in the bws falling down on patient's foot.To correct the issues with the unit, siemens replaced the defective switch button at the concerned site.The consumption rate of the defective part is below the threshold; therefore, no general problem with the switch was determined.To avoid any risk with bsw not being properly balanced, the user was asked not to use the system until siemens local service readjusts the balance according to the installation instructions and brings it back to specifications.The on-site service is planned to be performed by (b)(6) 2019.To avoid reoccurrence of the issue, the installation protocol (xpb4-410.812.01.16) will be updated by siemens to make the bsw balance check item clearer.

• Brand Name: MULTIX SELECT DR
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai, 20131 ; CH 20131
• MDR Report Key: 8550084
• MDR Text Key: 143079519
• Report Number: 3004754211-2018-58655
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K132934
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10569624
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 YR