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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ VIEWMATE Z W/SCAN ENGINE CART AND BATTERY; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
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ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ VIEWMATE Z W/SCAN ENGINE CART AND BATTERY; ULTRASONIC PULSED DOPPLER IMAGING SYSTEM Back to Search Results
Model Number 100105875
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2017
Event Type  malfunction  
Event Description
During the procedure, a burning smell was noted while using the scan engine and the ac adapter was found to be burnt when checked.The device was replaced and the procedure was completed with no adverse consequences to the patient.
 
Manufacturer Narrative
The reported event of a burning smell was confirmed.Based on the information provided to abbott and the investigation performed, the cause for the reported event was a failing digital board.
 
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Brand Name
VIEWMATE¿ VIEWMATE Z W/SCAN ENGINE CART AND BATTERY
Type of Device
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
Manufacturer (Section D)
ZONARE MEDICAL SYSTEMS, INC
420 north bernardo avenue
mountain view CA 94043
MDR Report Key8200484
MDR Text Key131581653
Report Number3004189859-2018-00002
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
PMA/PMN Number
K120703
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100105875
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/12/2018
Initial Date FDA Received12/27/2018
Supplement Dates Manufacturer Received03/21/2019
Supplement Dates FDA Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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