Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problem Insufficient Information (4580)
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 there was a device sensing issue on the arctic sun device.The baby's temperature was 36.9c when they left and 34.5c upon return, but the water temperature was not heating up as expected.The flow rate was 0.9 l/m.The temperature probe was replaced.They disconnected and reconnected the pads and the flow was up to 1.0 ¿ 1.1 l/m.The temperature was now up to 34.8c.The rewarm rate was set to 0.5c/hr.Ms&s advised that water was not heating up further because of the set rewarm rate.
 
Manufacturer Narrative
Per additional information received, bd has determined that this is not a reportable event.H11:section a through f - the information provided by bd represents all of 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.
 
Event Description
It was reported that there was a device sensing issue on the arctic sun device.The baby's temperature was 36.9c when they left and 34.5c upon return, but the water temperature was not heating up as expected.The flow rate was 0.9 l/m.The temperature probe was replaced.They disconnected and reconnected the pads and the flow was up to 1.0 ¿ 1.1 l/m.The temperature was now up to 34.8c.The rewarm rate was set to 0.5c/hr.Ms&s advised that water was not heating up further because of the set rewarm rate.Per follow up 1 on (b)(6) 2020 via charge nurse, stated that the issue was resolved and the root cause was an error by the nurse at the time.The patient was able to complete therapy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCTIC SUN 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10556136
MDR Text Key213004852
Report Number1018233-2020-06064
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-