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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR ARCTIC SUN TEMP CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR ARCTIC SUN TEMP CABLE Back to Search Results
Catalog Number 735-02
Device Problems Naturally Worn (2988); Protective Measures Problem (3015); Material Split, Cut or Torn (4008)
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 the cable was torn. The biomed stated the device alarmed that it could not heat or cool the water. A system diagnostics was done with just the fluid delivery line attached. The flow rate was 1. 7l/min, the inlet pressure was -7 and the circulation pump was 63%. The device displayed an alarm 15, an alert 50 and an alert 113. Ms&s explained the alarms. The biomed stated that the cable appeared worn needed to be replaced. The biomed enabled manual control and set the water temperature to 4c. T1 and t2 remained at 23c and the chiller was at 9c. The biomed set the water temperature to 38c and water temperature began to rise. The water temperature was 35c at end of call.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
Type of DeviceARCTIC SUN TEMP CABLE
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 Key10018865
MDR Text Key189988210
Report Number1018233-2020-02978
Device Sequence Number1
Product Code DWJ
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 health professional,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number735-02
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 Received06/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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