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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PAD
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PAD Back to Search Results
Catalog Number UNKNOWN
Device Problems Inaccurate Flow Rate (1249); 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 device was not returned.
 
Event Description
It was reported that the arctic sun device was getting zero flow with artic gel pads attached.Disconnected and reconnected the arctic gel pads with proper technique with no improvement in flow.Ran diagnostics and flow rate was 2 l/m range, the inlet pressure was -8 psi with the circulation pump command as 60%.Reconnected the arctic gel pads and no flow seen at the connector sites.Advised to try with arctic sun device first to check whether still had low flow when changed out the arctic sun pads.Explained and expected that the arctic gel pads were issue.Called back on hour, the using was waiting on a new set of the arctic gel pads and advised to sent the first set of arctic gel pad back.Per follow up via nurse on (b)(6) 2020, the nurse switched out the arctic gel pads and therapy was continuing without any further issues.The 1st set of pads were disposed of.
 
Event Description
It was reported that the arctic sun device was getting zero flow with artic gel pads attached.Disconnected and reconnected the arctic gel pads with proper technique with no improvement in flow.Ran diagnostics and flow rate was 2 l/m range, the inlet pressure was -8 psi with the circulation pump command as 60%.Reconnected the arctic gel pads and no flow seen at the connector sites.Advised to try with arctic sun device first to check whether still had low flow when changed out the arctic sun pads.Explained and expected that the arctic gel pads were issue.Called back on hour, the using was waiting on a new set of the arctic gel pads and advised to sent the first set of arctic gel pad back.Per follow up via nurse on (b)(6) 2020, the nurse switched out the arctic gel pads and therapy was continuing without any further issues.The 1st set of pads were disposed of.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "low flow due to over-lamination of foam to film due to temp controller set too high, belt speed controller set too low or failed, nip roller pressure regulator set too high, upper belt temperature is > 85 deg c".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic el pad product ifus were found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTIC GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10421359
MDR Text Key203884603
Report Number1018233-2020-05268
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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