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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH ISOLATION AMPLIFIER OTV-VGA-V2; SYSTEM, X-RAY, ANGIOGRAPHIC
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SIEMENS AG/SIEMENS HEALTHCARE GMBH ISOLATION AMPLIFIER OTV-VGA-V2; SYSTEM, X-RAY, ANGIOGRAPHIC Back to Search Results
Model Number 3099637
Device Problems Display or Visual Feedback Problem (1184); Smoking (1585); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2022
Event Type  Injury  
Event Description
Optical tv (otv) box started smoking under the control room counter which was being used for the ultrasound video.It was emitting smoke and became very hot to the touch.The otv is mounted under the control room counter at the operators console.The smoke bellowed up on the operator and it immediately caused a loss of ultrasound video which is critical for intracardiac echocardiography (ice)cases.There was no fire or patient injury as they were already past the critical part of the procedure with the ultrasound video and they saw the smoke soon enough to remove the power plug from the otv.Fda safety report id# (b)(4).
 
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Brand Name
ISOLATION AMPLIFIER OTV-VGA-V2
Type of Device
SYSTEM, X-RAY, ANGIOGRAPHIC
Manufacturer (Section D)
SIEMENS AG/SIEMENS HEALTHCARE GMBH
MDR Report Key15537087
MDR Text Key301195209
Report NumberMW5112397
Device Sequence Number1
Product Code IZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3099637
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2022
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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