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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO ICU MONITOR
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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO ICU MONITOR Back to Search Results
Model Number SCCS1002
Device Problems Display or Visual Feedback Problem (1184); Operating System Becomes Nonfunctional (2996)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the sensica device screen was unresponsive with a phantom touch.It was unknown whether the unit was cleaned or other events causing the phantom touch.The user did notice that one spot was still responsive on the top center of the screen despite the phantom touch being present.The nurse failed to turn the unit off, so they disconnected everything and let the power drain.Since then, the unit had been working fine without any issues.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the sensica device screen was unresponsive with a phantom touch.It was unknown whether the unit was cleaned or other events causing the phantom touch.The user did notice that one spot was still responsive on the top center of the screen despite the phantom touch being present.The nurse failed to turn the unit off, so they disconnected everything and let the power drain.Since then, the unit had been working fine without any issues.
 
Manufacturer Narrative
The reported issue was confirmed as design related.The root cause of the reported issue is being investigated under capa.It was unknown whether the unit was cleaned or other events causing the phantom touch.The user did notice that one spot was still responsive on the top center of the screen despite the phantom touch being present.The nurse failed to turn the unit off, so they disconnected everything and let the power drain.Since then, the unit had been working fine without any issues.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received.Labeling review was not required as the complaint was addressed by existing capa.Correction: a, f, h h11:section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
 
Event Description
It was reported that the sensica device screen was unresponsive with a phantom touch.It was unknown whether the unit was cleaned or other events causing the phantom touch.The user did notice that one spot was still responsive on the top center of the screen despite the phantom touch being present.The nurse failed to turn the unit off, so they disconnected everything and let the power drain.Since then, the unit had been working fine without any issues.
 
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Brand Name
SENSICA UO ICU MONITOR
Type of Device
SENSICA UO ICU MONITOR
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13453236
MDR Text Key286164480
Report Number1018233-2022-00394
Device Sequence Number1
Product Code EXS
UDI-Device Identifier00801741215773
UDI-Public00801741215773
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
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
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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