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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Device Problems Air Leak (1008); Restricted Flow rate (1248); Device Displays Incorrect Message (2591); No Flow (2991)
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 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.
 
Event Description
It was reported that when the patient returned from ct, the device gave a low air leak message and no flow. The flow rate was 0. 0 l/min, the circulation pump command was 100%. The nurse had a second device that the patient was put onto and flow remained zero. The pads were removed and a new set of pads and the flow rate was good.
 
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Brand NameUNKNOWN ARCTICGEL 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 Key7650040
MDR Text Key113162377
Report Number1018233-2018-02503
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
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 Received07/17/2018
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

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