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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DOPPLER PROBE; FLOWMETER, BLOOD, CARDIOVASCULAR
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DOPPLER PROBE; FLOWMETER, BLOOD, CARDIOVASCULAR Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2019
Event Type  malfunction  
Event Description
Doppler probe cover broke when surgeon was using in the patient's neck.
 
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Brand Name
DOPPLER PROBE
Type of Device
FLOWMETER, BLOOD, CARDIOVASCULAR
MDR Report Key8815618
MDR Text Key151862280
Report Number8815618
Device Sequence Number1
Product Code DPW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2019
Event Location Hospital
Date Report to Manufacturer06/12/2019
Type of Device Usage N
Patient Sequence Number1
Patient Age25550 DA
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