MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES YSIO MAX; SYSTEM, X-RAY, STATIONARY

Model Number 10762470

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

The manufacturing procedure for securing bolts of the lifting mechanics was not properly followed by an installer.This issue was identified internality before the system was handed over to the user.It is assumed that a workmanship error has occurred at the supplier facility.An immediate check of stock parts (47 parts) did not show the described above issue.However due to a potential risk of the upper bolts falling out causing table to tilt when loaded at the head end, siemens will inform customers of ysio max and multix fusion systems of the potential issue and initiate a field inspection as wells as corrective action.If needed.The investigation is on-going and a supplemental report will be provided if additional information becomes available.

Event Description

During factory installation of the table, the installer realized that one of the four bolts of the double scissor had nearly completely moved out of the hole due to a missing clip (lock ring).The clip on the other side of the table was checked and it was missing as well.There are no injuries attributed to this event.The reported issue was identified internally.

• Brand Name: YSIO MAX
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8560199
• MDR Text Key: 145916821
• Report Number: 3004977335-2016-48043
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10762470
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 04/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1