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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. SENSICA UO SYSTEM; URINOMETER, ELECTRICAL
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C. R. BARD, INC. SENSICA UO SYSTEM; URINOMETER, ELECTRICAL Back to Search Results
Model Number SCCS1002
Device Problems Break (1069); Failure to Power Up (1476); Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885); Detachment of Device or Device Component (2907); Inadequate User Interface (2958); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
Event Date 03/11/2022
Event Type  malfunction  
Event Description
11 incidents in relation to the sensica device, ranging from: touchscreen not functional- unable to re-start until machine battery dies, then, restarts and functions.Not reading urine output.Urine output inaccurate while patient is on diuretics.Inaccurate temperature readings, used another device and this resolved.Broken wires on ring.Urine collection bag suddenly falling disk broken.
 
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Brand Name
SENSICA UO SYSTEM
Type of Device
URINOMETER, ELECTRICAL
Manufacturer (Section D)
C. R. BARD, INC.
8195 industrial blvd
covington GA 30014
MDR Report Key13756913
MDR Text Key287111606
Report Number13756913
Device Sequence Number1
Product Code EXS
UDI-Device Identifier00801741215773
UDI-Public00801741215773
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCCS1002
Device Catalogue NumberSCCS1002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2022
Event Location Hospital
Date Report to Manufacturer03/14/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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