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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE
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SIEMENS MEDICAL SOLUTIONS USA INC. ACUSON; DIAGNOSTIC ULTRASOUND DEVICE Back to Search Results
Model Number P300 ULTRASOUND SYS
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2013
Event Type  malfunction  
Manufacturer Narrative
This failure was the result of a latent component failure in a board assembly.
 
Event Description
While scanning the pa230e probe gets hot.The customer described it as "uncomfortable".When asked she replied that "no patient was burnt or injured at all." she stated that when it starts getting too hot, that she stops scanning and lets the probe cool off.
 
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Brand Name
ACUSON
Type of Device
DIAGNOSTIC ULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA INC.
mountain view CA 94043
Manufacturer Contact
karen smith vp, reg. affairs
685 east middlefield road
mountain view, CA 94043
8004228766
MDR Report Key5607580
MDR Text Key43767310
Report Number3009498591-2015-00159
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
121384
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 05/03/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP300 ULTRASOUND SYS
Device Catalogue Number10852646
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2013
Date Device Manufactured12/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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