MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MOBILETT MIRA MAX; SYSTEM, X-RAY, MOBILE

Model Number	10594738
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint describes that four (4) screws holding the tube cover of the mobilett mira max system were missing and needed to be replaced.It is stated in the operator manual to perform a daily check of the system.During the daily check loose parts should be noticed.Currently it is not clear which exact screws were missing and which tube cover was associated with them.Since it was stated that the screws of the tube cover were missing, it is assumed that in worst case scenario, a minor to serious injury might be the outcome if a person were hit by the falling part.No injury or falling parts were communicated in this case.Potential patient information was not available.The issue is being reported with an abundance of caution.The reported event occurred in the united kingdom.
Additional Manufacturer Narrative
A facility contact name was not provided to siemens.Manufacturers preliminary analysis: the reason for the missing screws could not be determined yet.Investigation is ongoing.Initial corrective actions/preventive actions implemented by the manufacturer: the issue was resolved by replacing the screws at the affected site.No general problem has been detected for the installed base which requires an immediate action.A supplemental report will be submitted if additional information becomes available.Internal id# (b)(4).
Additional Manufacturer Narrative
The reported event was investigated in detail.The investigation showed there were four (4) out of the seven (7) screws for the collimator plastic covers (10656902) were missing.Due to the four (4) missing screws, the collimator plastic covers were slightly loose.The missing screws were noticed by the customer during normal usage of the system.During maintenance activities (on 13.10.2021) no problems were observed or detected relating to the collimator plastic covers or missing screws.In general, the collimator plastic cover is split into two parts that are linked together and fixed with seven (7) screws on the singe tank.The covers are generally fixed with seven (7) screws on the mira max system, so besides of the four (4) missing fixation screws no other parts of the cover should fall.The four (4) missing screws of the affected covers were replaced at customer site and the reported issue was resolved.The root cause for the four missing screws of the collimator plastic cover could not be determined.No general system problem was discovered.This complaint has been closed.Internal id# (b)(4).

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14851672
• Report Number: 3004977335-2022-33383
• Device Sequence Number: 6290032
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 10594738
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown