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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS UNKNOWN ARCTIC GEL PADS Back to Search Results
Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)
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.
 
Event Description
It was reported that there was low flow on the arctic sun device. The event log displayed alert 07, alert 02 (wo-00027484) and alert 1113. The stated that the water temperature was too cold. The nurse stated the rewarm rate was set to 0. 1c/hour and the current water temperature was 9c. The device was placed in manual control at 40c and the water temp was increased to 40c without any issue. However, when they disabled manual control and restarted therapy they got alert 02. Inlet pressure(ip) was 3. 4psi, system hours were 6671. 1 and pump hours were 5881. The nurse disconnected and reconnected pads using proper technique. Ip was -4. 9psi, flow rate (fr) was 0lpm, and the circulation pump (cp) was 100%. They have no other machines available (states all are giving low flow issues). They stopped therapy, emptied/disconnected pads and placed the device in manual control again. Just with the fluid delivery line attached: ip was -7psi, fr was 1. 8lpm and cp was 29%. They added the right chest pad: ip was -6. 8psi, fr was 2lpm, and cp was 53%. The added left chest pad: ip was -7. 1psi, fr was 1. 9lpm, and cp was 52%. The nurse connected both thigh pads at the same time: ip was -7psi, fr was 1. 9lpm, and was cp 54%. They stopped/disabled manual control and restarted rewarm again. Fr was initially 1. 9lpm, but the fr dropped to zero after a few minutes. Ms&s explained the biomed has three devices in his area. We can try testing them to see if one of them work.
 
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Brand NameARCTIC GEL PADS
Type of DeviceUNKNOWN ARCTIC 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 Key10155495
MDR Text Key195717927
Report Number1018233-2020-03859
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received07/17/2020
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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