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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC GEL PAD Back to Search Results
Catalog Number 318-02
Device Problems Product Quality Problem (1506); Temperature Problem (3022)
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 there were air pockets within the arctic gel pads. The twin neonates were being maintained at 36. 5c on the same device. The nurse stated the cloth side was intact and she stated it was not removed/lifted and resealed to the hydrogel. The patients' temperatures were 36. 2c, the water temperature was 40c, and the flow rate was 1. 2l/min. The nurse stated that one of the neonates did wet the pad, but not in the areas where the bubbling occurred. It was recommended that both pads be kept for evaluation. Additional information was received on 23jul2019 from the supervisor who stated that they stopped normothermia after 24 hours, due to another patient needing the device. Therapy was discontinued per the medical doctor's request. The twins were placed on radiant warmers to maintain their temperatures.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC GEL PAD
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 Key8860686
MDR Text Key153800981
Report Number1018233-2019-04446
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,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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