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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNKNOWN ARCTICGEL PADS; ARCTIC SUN GEL PADS
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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNKNOWN ARCTICGEL PADS; ARCTIC SUN GEL PADS Back to Search Results
Device Problems Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem 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.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 the device produced an air leak alarm, and the flow was very low, which caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
 
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 the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
 
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 the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
 
Manufacturer Narrative
Received 1 used arcticgel pad kit.The visual inspection noted a crack in the connector of the left thigh pad.The other connectors were found with no deformities in the tip of energy connectors.No other obvious defects were observed.Per the functional evaluation, each pad was submitted to the flow rate test with the arctic sun machine model 2000.The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: left chest pad: a total of 3.18 l/min m2 of flow rate were registered during the test.Left thigh pad: a total of 3.82 l/min m2 of flow rate were registered during the test.Right chest pad: the flow was never stabilized due to the energy connector was cracked causing air leakage.Right thigh pad: a total of 3.82 l/min m2 of flow rate were registered during the test.The flow rate of the right chest pad never was stabilized because the energy connector was damaged (deformed) causing air leakage.The flow rate was found to be acceptable for the others pads.The flow rate for this product must be above 2.4 l/min m2.The reported event was confirmed with an unknown cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states 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.¿ (b)(4).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 the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
ARCTIC SUN GEL PADS
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX  85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX   85621
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6190588
MDR Text Key63318708
Report Number1018233-2016-01834
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Event Location Home
Date Manufacturer Received01/25/2017
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
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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