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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN GEL PADS

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTICGEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-07-02
Device Problem No Flow (2991)
Patient Problem Underdose (2542)
Event Date 05/17/2016
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 therapy the pads were giving no flow; as a result, therapy was discontinued and the patient's temperature was maintained using other means.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
 
Manufacturer Narrative
Received 2 sets of 4 used arcticgel pads with the original unit packaging. The complaint is confirmed as cause unknown. During the visual evaluation, the following was found: set #1: visual inspection noted that the energy connectors have been damaged (energy connectors were collapsed where the energy connector is joined to the water supply and returned lines of the arctic sun) on the left thigh pad. No other damage was noted on the others pads. The trim patterns of the pads were found to be correct, and no obvious defects were noted in the laminate of the pads. The energy connectors were found to be correctly labeled. No obvious defects were found. Set #2: no damages were noted on the pads. The trim patterns of the pads were found to be correct, and no obvious defects were noted in the laminate of the pads. The energy connectors were found to be correctly labeled. No obvious defects were found. Per the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000. According to the flow rate test, the flow rate of the left chest pad (set #1) was never stabilized because the energy connector was damaged (deformed) causing an air leakage. The left thigh pad, right chest pad and right thigh pad were found acceptable. Set #2's flow rate of the left chest pad, left thigh pad, right chest pad and right thigh pad were all found acceptable. The flow rate for this product must be above 2. 4 l/min m2. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "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.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC 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
janna parks
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5719263
MDR Text Key48191694
Report Number1018233-2016-00729
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2017
Device Catalogue Number317-07-02
Device Lot NumberNGAP0217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2016 Patient Sequence Number: 1
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