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U.S. Department of Health and Human Services

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

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SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD MULTIX FUSION STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 10746665
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
According to post-market surveillance data for multix fusion, siemens is not aware of any similar occurrences in the field. The user was instructed to stop the device use until repairs. According to the provided information, siemens local service engineer visited the concerned site and lifted the two 3d stand wheels back onto the rails; he re-installed and tightly secured the end stoppers including the front transverse cover. The system was returned to the customer fully functional. Siemens is conducting an investigation of the reported event. A supplemental report will be submitted if additional information becomes available. Internal id # (b)(4).
 
Event Description
During a service call, siemens became aware of an event occurred on the multix fusion unit. The incident occurred with the transverse carriage. When the user moved the 3d stand transversely to align the tube to a wall stand, the front cover on the transverse carriage fell down to the floor with two end stoppers and the two of the 3d stand wheels ran off the rails track. This resulted in the 3d stand being stuck with no further movement possible. There are no injuries attributed to the event. The reported incident occurred in (b)(6).
 
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Brand NameMULTIX FUSION
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD
278 zhou zhu road
shanghai 20131 8
CH 201318
MDR Report Key11575289
MDR Text Key280460183
Report Number3004754211-2021-70617
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
PMA/PMN Number
K121513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10746665
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 03/26/2021 Patient Sequence Number: 1
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