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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249); Temperature Problem (3022)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2020
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 system was not able to rewarm the patient after being under hypothermia for 24 hours.Also, stated that the water temperature was below 30ºc and low flow rate was displayed.Per additional information, by changing the pads, the problem was resolved.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "improper design of pad connector- pad not connected to fluid delivery line".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 the system was not able to rewarm the patient after being under hypothermia for 24 hours.Also, stated that the water temperature was below 30ºc and low flow rate was displayed.Per additional information, by changing the pads, the problem was resolved.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key10289036
MDR Text Key199853343
Report Number1018233-2020-04620
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 company representative,other
Type of Report Initial,Followup
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight74
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