MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT XP HYBRID; MOBILE X-RAY SYSTEM

Model Number 1818454

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.The user was advised by the manufacturer against system usage until repairs are complete.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).

Event Description

The user informed siemens that they saw a gap between the single tank and the cover of collimator of the mobilett xp hybrid system.The user placed the collimator on the patient and turned it on.The collimator then separated from the flange.There is no patient involvement in this case.No injuries are attributed to this incident.The reported event occurred in (b)(6).

Manufacturer Narrative

The issue was investigated in detail.The described gap between the single tank and the cover of the collimator was noticed by the operator during the daily system check according to the user manual spr8-230.621.01.06.02.The collimator was loose; however, it has not fallen.In the upside-down position it was possible to remove the collimator.The investigation at the concerned customer site showed no defects at the four fixing points following the system checkup.However, one out of four fixation/adjustment screws was found to be loose.According to the system experts, it is not possible to remove the collimator when only one fixation screw is loose.Thus, it was concluded that a second screw was not properly fixed.It is assumed that during installation the fixation screws were tilted at the flange.After light/beam field adjustment the collimator shall be fixed according to the replacement of parts documentation (spr8-230.841.30.24.02 chapter 7.2 page 136).Last maintenance protocol of the device, performed on august 20 ,2019, was checked as well.No abnormalities, defects or damages were found.No service calls have been scheduled at the concerned site in the time between the last maintenance and the date of occurrence.The collimator has been already reassembled by the service and no further occurrences are known from the site.

• Brand Name: MOBILETT XP HYBRID
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; 91052 ; GM 91052
• MDR Report Key: 9504645
• MDR Text Key: 219779289
• Report Number: 3002808157-2019-11833
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K827929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: 1818454
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other