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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCITCSUN GEL PADS; ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 ARCITCSUN GEL PADS; ARCTIC GEL PADS Back to Search Results
Catalog Number 317-00-04
Device Problems Inaccurate Flow Rate (1249); Use of Device Problem (1670)
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.
 
Event Description
It was reported that the flow rate at the arctic gel was 0.6 l/m.The nurse had only one universal on the patient.Also, the nurse was explained that heater would not kick in with that low flow rate and so a full set of pads was needed.
 
Manufacturer Narrative
The reported event was confirmed.No sample was returned for evaluation.The failure mode was use-related, specifically incorrect product selection' with a root cause of 'use of incomplete set.' the lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "select the proper number, size and style pad for the patient size and clinical indication.However, the rate of temperature change and potentially the final achievable temperature is affected by pad surface area, patient size, pad placement and water temperature range.Best system performance will be achieved by using the entire pad set (4).If the entire set of pads is not used, the minimum flow rate may not be achieved." 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 the flow rate at the arctic gel was 0.6 l/m.The nurse had only one universal on the patient.Also, the nurse was explained that heater would not kick in with that low flow rate and so a full set of pads was needed.
 
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Brand Name
ARCITCSUN GEL PADS
Type of Device
ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10232569
MDR Text Key198309079
Report Number1018233-2020-04319
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 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number317-00-04
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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