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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARTIC GEL PADS

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARTIC GEL PADS Back to Search Results
Model Number 50000000E
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2022
Event Type  malfunction  
Event Description
It was reported that the neonate was cooling on the arctic sun device with 31. 21 hours left. The device sounded alert 02 (low flow). The nurse was concerned because the neonate was slightly above the target temperature of 33. 5c and the water temperature was still very warm. The nurse stated that the patient temperature was 33. 6c, water temperature was 39. 8c, flow rate was 0. 6l/min, event log showed several alert 02 (low flow) and no other alarms or alerts. The nurse stated that the system diagnostics water control showed flow rate was 0. 6l/min, inlet pressure was -7psi, circulation pump command was 28 percent. Mss asked the nurse to look for bends and kinks in the tubing. The nurse found a significant kink in the clear tubing under the blue foam where the tubing adjoins the pad. Nurse adjusted the tubing removing the kink and the fr rose to 1. 2l/min. Mss recommended the nurse to make sure the other nurses know to avoid kinking that area of tubing when adjusting the neonate's position. Mss explained that when a patient was at the target temperature the water will not always be cold. Mss explained how the water temperature adjusts every 2 minutes to keep the patient at the target temperature. After the tubing was adjusted, flow rate rose, and the water temperature started to decrease. The nurse stated that water temperature was 37. 5c when the call ended. Mss received a second call from nurse at 3:05 am. The nurse had accidentally turned the device off and was anxious about the settings being saved. Mss explained that you just press the continue or resume current patient button and to resume therapy and no settings were lost.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameUNKNOWN ARCTICGEL PADS
Type of DeviceARTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key14363427
MDR Text Key291624941
Report Number1018233-2022-03626
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/11/2022 Patient Sequence Number: 1
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