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 Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.The collimator was reattached to the unit; the system was returned to use.Is working fine since the correction.A supplemental report will be submitted if additional information becomes available.Internal complaint id (b)(4).

Event Description

Siemens healthineers was informed by its service organization that the collimator was dislocated from the mobilett xp hybrid system.The cable assembly prevented that the collimator was falling down.There is no patient involvement in this case.The reported incident occurred in (b)(6).

Manufacturer Narrative

The described issue was examined.According to the information provided by siemens local service organization, the collimator got detached from the x-ray tube, however the cable assembly prevented it from falling to the ground.Based on the information from the local service technician and provided images, the collimator fixation screws were secured with loctite from the factory.In the past year no other service calls related to collimator detachments have been recorded by siemens service.No other activities, indicating to be a possible cause of the incident, were communicated.Furthermore, no defects at the fixing points or other parts could be detected after checkup.After all, the root cause could not be determined.At the concerned site the collimator has been remounted and the screws locked with loctite by the service technician.The system was returned to use after the correction.

• Brand Name: MOBILETT XP HYBRID
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8811212
• MDR Text Key: 151725131
• Report Number: 3002808157-2019-88532
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

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: Health Professional
• Device Model Number: 1818454
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other