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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE

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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU; SENSICA DEVICE Back to Search Results
Model Number SCCS1002
Device Problem Intermittent Loss of Power (4016)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/11/2022
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 was shutting off and the 4th gold pin was damaged.
 
Event Description
It was reported that the sensica device was shutting off and the 4th gold pin was damaged.
 
Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.The device was not returned.
 
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Brand Name
SENSICA UO MONITOR ICU
Type of Device
SENSICA DEVICE
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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13712648
MDR Text Key286918580
Report Number1018233-2022-01179
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 09/08/2022
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? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/11/2022
Initial Date FDA Received03/09/2022
Supplement Dates Manufacturer Received09/07/2022
Supplement Dates FDA Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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