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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); Unable to Obtain Readings (1516); Output Problem (3005); Reset Problem (3019)
Patient Problem Insufficient Information (4580)
Event Date 01/09/2022
Event Type  malfunction  
Event Description
Patient safety and htm have received multiple reports regarding these devices with the model number sccs1002.In the past 2 months, from (b)(6) 2021 to (b)(6) 2022, there have been 54 reported incidents.This is the example from the machine listed in this report: the urometer screen froze.I could not reset it (unplug it, hold the power button) to make it work.I lost a couple hours of urine output, when we were monitoring his output closely.Other incidents: event 1: urometer non-functional corrective maintenance.Event 2: says touch screen is broken corrective maintenance.Event 3: equipment does not turn on.Corrective maintenance.Event 4: screen is frozen corrective maintenance.Event 5: corrective maintenance.Event 6: urine meter is not working corrective maintenance.Event 7: will not turn on.Corrective maintenance.Event 8: monitor screen is not working corrective maintenance.Event 9: screen is frozen corrective maintenance.Event 10: urine output measurement is off.Corrective maintenance.Event 11: not working corrective maintenance.Event 12: error msg 40 - frozen screen corrective maintenance.Event 13: tubing sensor is not working, corrective maintenance.Event 14: not reading.Corrective maintenance.Event 15: screen is completely non-responsive to touch.Unable to restart unit to attempt to fix.Event 16: not functioning correctly.States "ring failure".Corrective maintenance event 17: screen is frozen corrective maintenance.Event 18: sensica urometer screen is unresponsive.Corrective maintenance event 19: urometer screen does not work, and device does not record data.Event 20: new urine monitoring machine is not working and is out of order.Event 21: urometer screen is hardly responsive making it very difficult to use.Event 22: please pick up this broken urine flowmeter and repair, is not working sitting in our storeroom, thanks.Event 23: frozen corrective maintenance.Event 24: tubing port is broken doesn't register.Corrective maintenance.Event 25: screen in frozen.Corrective maintenance.Event 26: please send someone to fix a sensica urometer.It is broken, the face of the device is upside down and backwards.Please fix asap, we do not have any extra devices to cover a broken one.Thank you corrective maintenance.Event 27: scale not accurate - sending unit in for repair.Corrective maintenance event 28: certificate expiration approaching.Event 29: screen is frozen.Corrective maintenance.Event 30: screens are frozen.Can not change anything.Corrective maintenance.Event 31: device will not recognize ring or tubing when in tubing holder, despite adhesive marker strip appropriately placed.Corrective maintenance.Event 32: touch screen on urine monitor not working- at nursing station corrective maintenance.Event 33: prongs bent on front of machine.Corrective maintenance.Event 34: urometer is missing a chord.Event 35: we have 3 of the new criticores that do not work.Event 36: urometer broken.Corrective maintenance.Event 37: load cell pins damaged requires repair - needs replacement power cord.Event 38: touch screen does not work.Corrective maintenance.Event 39: unit is cracked.Corrective maintenance.Event 40: the device stop doing hourly count for urine.Corrective maintenance.Event 41: unit not accurate - send to bd for repair.Corrective maintenance.Event 42: error msg not deleting tubing.Corrective maintenance.
 
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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 Key13479723
MDR Text Key285228834
Report Number13479723
Device Sequence Number1
Product Code EXS
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 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSCCS1002
Device Catalogue NumberSCCS1002
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2022
Event Location Hospital
Date Report to Manufacturer02/08/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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