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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC GEL PADS Back to Search Results
Device Problem Break (1069)
Patient Problem Blood Loss (2597)
Event Type  malfunction  
Manufacturer Narrative
The reported event was inconclusive, as the device was not returned for evaluation. A potential failure mode could be ¿air leakage into the system. ¿ a potential root cause for this failure could be "user cuts or punctures pads or pad lines. " the lot number is unknown; therefore, the device history record could not be reviewed. Although the product family is unknown, the z300-unknown arctic gel pads ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that while a cardiac arrest patient was being cooled on the arctic sun, some of the patient's blood was sucked up into the arctic sun pads and device. The complainant noted that chest compressions had been performed for four hours and that the patient had been bleeding a lot. She had no information on where the blood was coming from. The nurse requested information on how to remove the blood from the device. Additional information was received from the facility on 13jan2020 that the pads had allegedly broke, which allowed the blood to enter the device. Technical support explained to the facility that if the pads broke, it was unlikely that the flow rate would be high enough to suck blood into the device. A call was received from a clinical equipment expert and a clinical risk specialist on 15jan2020. They stated that the pads had been disposed of and the pad size was unknown. She denied that the pads were placed on top of any injuries and that the pads did not cause any injuries. She also stated that an auto-compression device had been used on top of the chest pads and was unsure if it was affecting the flowrate. She was unable to provide any information on where exactly the blood was coming from on the patient. She noted "the blood was everywhere; the patent was in very critical condition. " they wanted to send the device in to be internally decontaminated. It was noted that the device was tested and was found to have no issues.
 
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Brand NameARCTICSUN GEL PADS
Type of DeviceARCTIC 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 Key9672109
MDR Text Key177838788
Report Number1018233-2020-00776
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 Biomedical Engineer
Type of Report Initial
Report Date 02/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
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 Received01/13/2020
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 Initial

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