MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MULTIX PRO; RADIOLOGIC TABLE

Model Number 5902973

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

The cause of the incident is assessed as individual workmanship error of the user trying to perform service on the system.

Event Description

Siemens became aware of an adverse event with the multix pro system.The user had performed a repair of the patient handgrip and incorrectly placed a snap ring that locks the hand grip in position.The repair work was done without siemens' involvement.The repair was performed incorrectly; however, the user released the unit for regular clinical operation.During an examination, a patient handle that is supposed to be firmly fitted became loose and hit patient's head when she tried to grab it.According to the user, the patient required staples to stitch the wound.No other details were provided.

Manufacturer Narrative

**resubmission of initial report as per fda on 4/3/19** the described issue was investigated based on the information provided by the service engineer on the site; the returned complaint part (patient handgrip, material number 1292379) was examined.Prior to the described event the customer had repaired the patient handgrip without involving authorized service personnel.Hereby, the snap ring that holds a spring in place for proper axel movement was not positioned correctly.As a consequence the handgrip did not switch into operational position and remained movable.When the patient grasped the handgrip, it swung down and hit the patient.The reason for the initial defect of the part cannot be determined.The damage found on the snap ring may be caused by improper use of the handgrip.No material failure was identified and no general problem is known regarding this component.At the concerned customer system the handgrip was replaced by a service technician.The customer was advised that according to safety instructions any system repair must be performed by qualified and authorized personnel only.

• Brand Name: MULTIX PRO
• Type of Device: RADIOLOGIC TABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstr.1; forchheim, 91301 ; GM 91301
• MDR Report Key: 8510799
• MDR Text Key: 141913272
• Report Number: 3004977335-2018-42768
• Device Sequence Number: 1
• Product Code: IZZ
• Combination Product (y/n): N
• PMA/PMN Number: K971452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5902973
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other