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U.S. Department of Health and Human Services

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

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SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD MULTIX FUSION MAX STATIONARY X-RAY SYSTEM Back to Search Results
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.
 
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Brand NameMULTIX FUSION MAX
Type of DeviceSTATIONARY 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 Key11372664
MDR Text Key233310567
Report Number3004754211-2021-66193
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11020660
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
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