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

Model Number 10594738

Device Problem Use of Device Problem (1670)

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

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested by siemens factory experts.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

During safety checks of a newly installed mobilett mira max unit siemens engineer found that the system was failing the protective ground wire resistance testing.There are no injuries attributed to this event.

Manufacturer Narrative

The issue was investigated in detail.During system installation at this site it was found that the front cover failed grounding resistance test.This grounding resistance test is also performed during the factory final testing and it was found within acceptable thresholds on this particular unit.During transportation and time lapse between operations the resistance between system parts may slightly increase in comparison to the measurements before (e.G.Oxygen film).According to the local service this cover yielded a measurement value of 0.55 ohm, however, after cleaning with a wire brush the cover yielded a value of 0.07 ohm, which is still an acceptable value.Checking and correcting of the grounding resistance is a required step during installation, maintenance and reactive service.Additional system covers were tested on the production line and it was determined that they all fulfill the maximum resistance thresholds.If after system delivery the grounding resistance measures are above the threshold, the system will not be handed over to the customer.The investigation showed that no risk is known from the field.No general problem, hazard or injury was communicated due to grounding resistance failure.However, the cover at this facility was replaced as a precaution.This report was submitted december 1, 2017.

• Brand Name: MOBILETT MIRA MAX
• Type of Device: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 7075441
• MDR Text Key: 142796841
• Report Number: 3002808157-2017-85813
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10594738
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other