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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC GEL PADS Back to Search Results
Catalog Number 317-09
Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)
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 information provided by bard 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 bard. The device was not returned.
Event Description
It was reported that the device was displaying a low air leak and the flow rate was 0lpm while cooling a patient. The patient's temperature was 33. 5c and the target temperature was 33. 3c. The water temperature was 17. 1c. Four large pads were in use and coverage was appropriate. Per troubleshooting, the complainant disconnected and reconnected the pads. Upon restarting the device, the flow rate immediately stopped. Per the event log, there were multiple alert 01s and alert 02s since 4:18 am. The complainant declined further troubleshooting and obtained a second device. Upon call back approximately 40 minutes later, the patient had been switched to the second device (s/n (b)(4)) and a second set of pads. The device was still displaying a low air leak. The flow rate was 1. 4lpm. The event log showed an alert 01 and an alert 02. The complainant disconnected and reconnected the pads holding only the blue foam tubing and the flow rate stabilized at 3. 0lpm. She had thrown away the first set of pads. The patient was able to complete therapy with no additional flow rate issues.
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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
amy gravley
8195 industrial blvd
covington, GA 30014
MDR Report Key7453699
MDR Text Key106599020
Report Number1018233-2018-01352
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 05/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-09
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 Received05/07/2018
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