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

Model Number	10594738
Medical Device Problem Codes	No Display/Image (1183); No Device Output (1435); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the event.A supplemental report will be submitted if additional information is received.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of a malfunction that occurred on the mobilett mira max.Thorax acquisition could not be performed on a newborn patient in the intensive care unit.The patient was in critical condition when the malfunction occurred.A lifesaving procedure was initiated by medical personnel.No further impairments or injuries have been communicated to siemens.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
The issue was investigated in detail.The investigation showed that the pc for the medical device mira max (11131575) was defective and caused the situation that the thorax acquisition could not be performed timely.The provided log files were investigated as well, however, no information could be found for the time of the event due to the flc pc not being started.According to the log files, the detector was successfully attached, and the wi-fi signal was good.An error message was found which indicates that the cable connection from flc pc to the generator was instable.The investigation indicates that the issue was caused by a hardware problem within the flc pc.Additionally, to the flc pc also the stu-v4 (10656662) and the hard disk 1 tb 5400rpm (11433521) were replaced.The spare part consumptions of the replaced components were checked and all show values below the defined threshold.No general or systematic issue is known.

• Brand Name: MOBILETT MIRA MAX
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; forchheim, 91052 ; GM 91052
• MDR Report Key: 10992747
• Report Number: 3002808157-2020-57321
• Device Sequence Number: 11632329
• Product Code: IZL
• UDI-Device Identifier: 04056869009131
• UDI-Public: 04056869009131
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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
• Initial Date Received by Manufacturer: 11/27/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other