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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS INC SIEMENS ACUSON S2000; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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SIEMENS MEDICAL SOLUTIONS INC SIEMENS ACUSON S2000; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number ACUSON S2000
Device Problems Loss of Power (1475); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2019
Event Type  malfunction  
Event Description
The end user stated, "ultrasound machine on standby, but while doing portable went through "syngo", a complete shut down.12 minute delayed service, tech at patient's bedside while machine does complete shut down twice in a row".My understanding is that while they were using the machine it did a complete shut down.We had siemens the manufacturer come out and they stated that the stand by battery needed to be replaced.This battery had been replaced only 2 months ago.Manufacturer response for ultrasound, siemens (per site reporter).They felt that the battery was bad and they came out and replaced it.Unit seems to be working 4 or 5 days later.However it is unclear to me as to why a battery would cause this machine to shut off while it is plugged in to ac power.
 
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Brand Name
SIEMENS ACUSON S2000
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS INC
40 liberty boulevard
malvern PA 19355
MDR Report Key8353497
MDR Text Key136605670
Report Number8353497
Device Sequence Number1
Product Code IYN
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberACUSON S2000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/12/2019
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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