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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problem Alarm Not Visible (1022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/23/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device had been alerting every 15 seconds, but there was no alert message. It was noted that the patient was pediatric and xs size pads were used. The event log showed alarm 14 (patient temperature 1 probe out of range), alarm 15 (unable to obtain a stable patient temperature) and alert 11 (patient temperature 1 below low patient alert). The patient temperature was registering on device at 37c, and all alerts or alarms were from much earlier. Mss had nurse to stop therapy, drain pads and power off device and powered back on and continued current patient. The flow rate was stabilized at 2. 4lpm. The nurse asked how to find out what an alert or alarm means when they view the numbers in the event log. Mss walked nurse through accessing the alarm or alert meanings through help index. The nurse noted alarms were red and stop therapy while alerts were yellow and were warning messages.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. 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.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
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 Key14657199
MDR Text Key293866976
Report Number1018233-2022-04533
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
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 11/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/10/2022 Patient Sequence Number: 1
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