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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTICSUN GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Inaccurate Flow Rate (1249); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 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 the patient overshot the target temperature while on the arcticsun device. The patient's temperature was 38. 3c, the target temperature was 37c, the water temperature was 30. 9c, and the flow rate was 1. 9l/min. The nurse stated that the device was showing an alert 113 for the last few hours. Temperature 4 was 4. 4c. The nurse was advised to send the device to the biomed for evaluation. Additional information was received from the facility on 25apr2019. She stated that the patient reached the target temperature in normothermia mode, but therapy was stopped due to the alert 113. She stated the device was sent to the biomed for evaluation.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTICSUN GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8598975
MDR Text Key144960016
Report Number1018233-2019-02436
Device Sequence Number1
Product Code DWJ
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
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

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