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

Model Number 11020660

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/27/2021

Event Type  Injury  

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 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
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD; 278 zhou zhu road; shanghai 20131 8; CH 201318
• Manufacturer (Section G): SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD.; 278 zhou zhu road; shanghai, 20131 8; CH 201318
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 11372664
• MDR Text Key: 233310567
• Report Number: 3004754211-2021-66193
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 04056869050713
• UDI-Public: 04056869050713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162971
• 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
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11020660
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• 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