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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 Problem Device Sensing Problem (2917)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the sensica device would not recognize bag or tube.
 
Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was evaluated upon receipt.The device was functional tested and functioned as normal.Bag, tube and ring all registered correctly.As the reported event is unconfirmed, dhr review is not required.The reported event is unconfirmed, labeling/packaging review is not required.Correction: h h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported that the sensica device would not recognize bag or tube.
 
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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 Key13584617
MDR Text Key286445347
Report Number1018233-2022-00813
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 05/31/2022
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 NumberSCCS1002
Device Catalogue NumberSCCS1002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/01/2022
Initial Date FDA Received02/23/2022
Supplement Dates Manufacturer Received05/31/2022
Supplement Dates FDA Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
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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