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

Model Number	1818454
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was communicated that a loose cable in the power plug and a short circuit in the pin area were found.At this point in time it is assumed that the observed sparks were caused by a defective power plug.Siemens local service replaced the power supply plug on the system.The user was advised not use the system until the main cable is replaced.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens was informed about sparks that were generated from the power plug while charging the mobilett xp hybrid device.There is no patient involvement in the reported case.There are no injuries attributed to this event.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
The issue was investigated in detail.The investigation showed that the main plug was defective and caused the described situation.It was confirmed by the service organization that a loose cable inside the main plug caused a short circuit and, therefore, lead to the described sparks while charging.According to the information received by the service organization the main plug was immediately replaced and the complete entire cable winder was replaced later.Since the defective plug was no longer available, reasons to why the cable became loose could not be determined.The described issue was solved at the customer site by service technician with replacement of the affected part.

• Brand Name: MOBILETT XP HYBRID
• Common Device Name: MOBILE X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 10747234
• Report Number: 3002808157-2020-51498
• Device Sequence Number: 3125514
• Product Code: IZL
• UDI-Device Identifier: 04056869009094
• UDI-Public: 04056869009094
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K827929
• 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): 10/28/2020

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: 1818454
• Device Lot Number: 5195
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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