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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO STATIONARY X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH YSIO STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 10281013
Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
Siemens is conducting an investigation of the reported incident. A supplemental report will be submitted if additional information becomes available. Internal id # (b)(4).
 
Event Description
A user reported that a cable holder set on the ysio unit dropped down from the rail. A screw that attaches the cable holder to the rail was missing. Siemens is not aware whether persons were present in the exam room when the incident occurred. However, no injuries are attributed to this event. The reported event occurred in (b)(6).
 
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Brand NameYSIO
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
erlangen, 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
erlangen, 91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key11373901
MDR Text Key234229069
Report Number3002808157-2021-68553
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K081722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
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? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10281013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
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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