MAUDE Adverse Event Report: SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD MULTIX FUSION MAX; STATIONARY X-RAY SYSTEM

Model Number	11020660
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the provided information, the concerned system is being heavily used at the facility, with large number of patient loads.The detector has been taken in and out of the tray frequently due to actual clinical workflow at the site (e.G.Different ogps were frequently switched, it shown about average 25 times per day, and up to 52 times on (b)(6) 2021).The concerned detector cover worn off due to facility's environment as well as operator's not paying attention during system use.No other general issues were identified with mutlix fusion max units.It was recommended to replace the detector to avoid similar incidents from occurring, however, this advice was not accepted by the user as the detector is functioning properly.Siemens local service informed the user about potential risks and advised to pay more attention while using the concerned detector according to the operator manual.Internal id # (b)(4).
Event or Problem Description
While performing service on the multix fusion max unit, siemens local service engineer noticed that one of the four steel corners of the detector popped off from the detector.The steel corner was jammed inside the detector's bucky tray.The user was covering the peeling detector cover with tape.Siemens was informed of a minor injury caused by the peeling detector cover.The operator slightly cut hand on the peeling edge; however, no medical intervention was required.

• Brand Name: MULTIX FUSION MAX
• Common Device Name: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai 20131 8; CH 201318
• MDR Report Key: 11372664
• Report Number: 3004754211-2021-66193
• Device Sequence Number: 19768933
• Product Code: KPR
• UDI-Device Identifier: 04056869050713
• UDI-Public: 04056869050713
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K162971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11020660
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/24/2021
• 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