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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTIC SUN GEL PADS

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MEDIVANCE, INC. ¿ 1725056 ARTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09-02
Device Problems Inaccurate Flow Rate (1249); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the flow rate on the arctic sun device was 0. 6l/min. The patient had been maintaining normothermia for several days. The patient temperature was 37. 3c with a target temperature of 37c. The water temperature was 8. 6c, the pump hours were 3740. 3, and the system hours were 4245. 5; with pads attached, the flow rate read 0. 5l/min, the ip was -7. 3psi, and the cp was 29%. Per troubleshooting with ms&s, the nurse was instructed to empty and disconnect the pads. Manual control was enabled with the water temperature was set to 10c. Without the pads attached, the flow rate was 1. 8l/min, the ip was -7psi, and the cp was at 53%. The pads were then added back sequentially. All pads had 0-0. 2l/min flow rate and the ip was -3 to -6. 1psi. The nurse stated she would change out the device first, and if the flow rate did not rise then she would change the pads. After one hour, the nurse stated that the patient was taken off of the device for a ct scan. She obtained a new device, and called back to be instructed through setting up the new device and restarting therapy on the patient. The flow rate on the new device settled at 2. 1l/min and the patient temperature was 38. 6c. The nurse was advised that the patient temperature had risen since he was disconnected for ct scan. Ms&s explained that the water would get cold to bring the patient temperature down to target again. The nurse was advised to send the first device to biomed for evaluation.
 
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Brand NameARTICGEL PADS
Type of DeviceARCTIC SUN 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 Key8506415
MDR Text Key142129693
Report Number1018233-2019-01913
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 05/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue Number317-09-02
Device Lot NumberNGCZ0256
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 Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2019
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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