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U.S. Department of Health and Human Services

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

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTICSUN GEL PADS Back to Search Results
Catalog Number 317-07
Device Problems Contamination (1120); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964); No Flow (2991)
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. The device was not returned.
 
Event Description
It was reported that the patient soiled the first set of medium pads, resulting in a second set of medium pads being used on the patient. The second set of medium pads produced an alert 01 and alert 02. Per troubleshooting, the device was placed in manual mode with only the fdl attached, and the flow settled at 1. 6lpm, the ip was -7. 0psi and the circulation pump was at 58%. The left chest pad was attached and the circulation pump rose to 100%, and the ip was -0. 7psi; however, there was no improvement when changing valve sets. The results were the same with the right chest pad, as the ip was -0. 4psi and the water level was 4 bars. Therefore, the second set of medium pads were replaced with a third set of medium pads, which resulted in no flow. Subsequently, the arctic sun 5000 device was replaced with an arctic sun 2000 device, and therapy resumed on the third set of medium pads and the arctic sun 2000 without any further issues.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use states 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.
 
Event Description
It was reported that the patient soiled the first set of medium pads, resulting in a second set of medium pads being used on the patient. The second set of medium pads produced an alert 01 and alert 02. Per troubleshooting, the device was placed in manual mode with only the fdl attached, and the flow settled at 1. 6lpm, the ip was -7. 0psi and the circulation pump was at 58%. The left chest pad was attached and the circulation pump rose to 100%, and the ip was -0. 7psi; however, there was no improvement when changing valve sets. The results were the same with the right chest pad, as the ip was -0. 4psi and the water level was 4 bars. Therefore, the second set of medium pads were replaced with a third set of medium pads, which resulted in no flow. Subsequently, the arctic sun 5000 device was replaced with an arctic sun 2000 device, and therapy resumed on the third set of medium pads and the arctic sun 2000 without any further issues.
 
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Brand NameARCTIC GEL PADS
Type of DeviceARCTICSUN 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 Key6309146
MDR Text Key67120992
Report Number1018233-2017-00340
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/07/2017 Patient Sequence Number: 1
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