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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS; ARCTIC GEL PADS Back to Search Results
Catalog Number 317-07-02
Device Problems Disconnection (1171); Connection Problem (2900); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
 
Event Description
It was reported that during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: mfr site.
 
Event Description
It was reported that during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.
 
Event Description
It was reported that during on going therapy no flow built up.There was no connection under the insulation.Subsequently, the pads were exchanged, and the arctic sun worked.
 
Manufacturer Narrative
Received 1 used articgel pad kit for evaluation.The reported event was confirmed.During visual inspection, it was noted that one of the connectors was disconnected from the tubing in the left leg pad.Dimensional evaluation showed that the tube was found out of specification.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use state the following: "5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit." correction: concomitant medical products.
 
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Brand Name
ARCTICGEL PADS
Type of Device
ARCTIC GEL PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7403442
MDR Text Key104907201
Report Number1018233-2018-01066
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,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue Number317-07-02
Device Lot NumberNGBY1695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2018
Initial Date Manufacturer Received 03/16/2018
Initial Date FDA Received04/06/2018
Supplement Dates Manufacturer Received06/08/2018
06/22/2018
Supplement Dates FDA Received06/14/2018
06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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