• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 ARCTIC GEL PADS ARCTIC SUN GEL PADS Back to Search Results
Catalog Number 317-09-02
Device Problems Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)
Patient Problems Erythema (1840); Alteration In Body Temperature (2682)
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 allegedly produced a pad associated, low flow rate. The patient was reportedly obese and the hospital placed large pads on the upper part of her; however, the pads did not provide full coverage. It was later reported that the patient was being treated for persistent pyrexia, and that her temperature frequently fluctuated. The flow was observed and was reported as moderate to poor; however, the cause was undetermined. It was also reported that the lines were kinked and the water was completely filled; however, the device produced an alarm that stated that the water temperature was below 10 degrees for 8 out of 10 hours of therapy. Additionally, it was reported that the patient's skin began to appear red in color, which contributed to the decision to remove the pads. Subsequently, the pads were removed and replaced, and therapy was completed using the second set of pads.
 
Manufacturer Narrative
Received 2 used large arcticgel torso pads only. The visual inspection noted no obvious defects that would have contributed to the reported problem. The pads were reviewed and were noted to have use evidence. The pads were found with the trim pattern correct, and the energy connectors were found free of damages and presented a good connection. Per the functional evaluation, the pads were submitted to the flow rate test with the arctic sun machine model 2000. The pads were connected to the arctic sun machine model 2000 during 10 minutes, see details below: right chest pad: a total of 3. 17 l/min m2 of flow rate were registered during the test. Left chest pad: a total of 3. 90 l/min m2 of flow rate were registered during the test. According the test method, the flow rate was found to be acceptable on all the returned pads. The flow rate for this product must be above 2. 4 l/min m2. The reported event could not be confirmed as the product met specification. 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. ¿ 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 allegedly produced a pad associated, low flow rate. The patient was reportedly obese and the hospital placed large pads on the upper part of her; however, the pads did not provide full coverage. It was later reported that the patient was being treated for persistent pyrexia, and that her temperature frequently fluctuated. The flow was observed and was reported as moderate to poor; however, the cause was undetermined. It was also reported that the lines were kinked and the water was completely filled; however, the device produced an alarm that stated that the water temperature was below 10 degrees for 8 out of 10 hours of therapy. Additionally, it was reported that the patient's skin began to appear red in color, which contributed to the decision to remove the pads. Subsequently, the pads were removed and replaced, and therapy was completed using the second set of pads.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC GEL 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
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6309090
MDR Text Key66928391
Report Number1018233-2017-00339
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 health professional,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 04/04/2017
1 Device was Involved in the Event
0 Patients were 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 Expiration Date08/31/2017
Device Catalogue Number317-09-02
Device Lot NumberNGAV1650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-