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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 PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; UNKNOWN ARCTIC GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Inaccurate Flow Rate (1249); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
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 there was an low flow alert (alert 02) on the arctic sun device.The user stated that was not by arctic sun device.Nurse went through all trouble shooting without success then the nurse decided to switch out the arctic gel pads and the arctic sun device was functioning properly.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.The failure mode for this failure is "tubes not fully seated on mani-folds / low flow".A potential root cause for this failure is "operator error".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 gel 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.H3 other text : the device was not returned.
 
Event Description
It was reported that there was an low flow alert (alert 02) on the arctic sun device.The user stated that was not by arctic sun device.Nurse went through all trouble shooting without success then the nurse decided to switch out the arctic gel pads and the arctic sun device was functioning properly.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10574162
MDR Text Key208750377
Report Number1018233-2020-06162
Device Sequence Number1
Product Code DWJ
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 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
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 Received10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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