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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MULTIX FUSION; STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL
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SIEMENS MEDICAL SOLUTIONS USA, INC. MULTIX FUSION; STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Contusion (1787); Tissue Damage (2104)
Event Date 10/22/2019
Event Type  malfunction  
Event Description
Patient was to have a lateral x-ray image.The patient was instructed not to stay in a lateral position and not use the table for support.When the table moved, the patient reached out to the side of the radiology table and their fingers got pinched.The radiology tech noticed in other radiology rooms that when an image is taken, the table locks into position.With this table that is not the case.Patient received small contusion on their hand.Manufacturer response for radiographic systems, (brand not provided) (per site reporter).The vendor has made a suggestion to offer hand rails to prevent such an event.
 
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Brand Name
MULTIX FUSION
Type of Device
STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 north barrington rd
hoffman estates IL 60192
MDR Report Key9676477
MDR Text Key177979311
Report Number9676477
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/04/2019,11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/04/2019
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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