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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM; SENSICA DEVICE
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C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO SYSTEM; SENSICA DEVICE Back to Search Results
Model Number SCCS1002
Device Problems Device Handling Problem (3265); Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Event Description
It was reported that the sensica device would power off shortly after turning the device on, usually when they were trying to start the patient monitoring session.Per follow-up information received on 12feb2022, sensica device was used on the patient, no patient injury reported.The treatment was completed with the same device.It was stated that they investigated this issue and immediately found that the incorrect power supply was plugged into the device.The power supply was not a bd one or similar in appearance at all, besides the same barrel connector for power at the base.The nurse did not know if the power supply was delivered with the sensica device, but they said this power supply was already in the room.Bd representative could not locate the proper sensica power supply in the room.The device was likely low on power, so it would power itself down.The correct power supply was sourced, and then the device was powered on and a patient monitoring session started.Currently, the device was working properly.
 
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 power off shortly after turning the device on, usually when they were trying to start the patient monitoring session.Per follow-up information received on 12feb2022, sensica device was used on the patient, no patient injury reported.The treatment was completed with the same device.It was stated that they investigated this issue and immediately found that the incorrect power supply was plugged into the device.The power supply was not a bd one or similar in appearance at all, besides the same barrel connector for power at the base.The nurse did not know if the power supply was delivered with the sensica device, but they said this power supply was already in the room.Bd representative could not locate the proper sensica power supply in the room.The device was likely low on power, so it would power itself down.The correct power supply was sourced, and then the device was powered on and a patient monitoring session started.Currently, the device was working properly.
 
Manufacturer Narrative
Upon further review, bd has determined this event is not reportable.The device was not returned.
 
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Brand Name
SENSICA UO SYSTEM
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 Key13693466
MDR Text Key286996662
Report Number1018233-2022-01120
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 07/28/2022
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
Date Returned to Manufacturer02/09/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2022
Initial Date FDA Received03/08/2022
Supplement Dates Manufacturer Received07/28/2022
Supplement Dates FDA Received08/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2021
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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