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

MAUDE Adverse Event Report: DYMAX CORP. -2523003 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE

  • 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
 

DYMAX CORP. -2523003 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM ARCTIC SUN DEVICE Back to Search Results
Catalog Number 5000-00-00
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2017
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 during therapy, the device leaked from the drain ports. It was confirmed that the fill tube was not stored in the drain port; however, it appeared that the ports were broken. Therapy was interrupted in order to replace the device, and, therapy continued with no further issues.
 
Manufacturer Narrative
The reported issue was confirmed. The device was serviced by biomedical engineering at the customer facility. The root cause of the reported issue of the device leaking was isolated to broken drain valve. A root cause analysis to sub assembly was only by the biomedical technician, potential issue of the leakage caused by mechanical issues with the internal spring mechanism not sealing properly or internal mechanism becoming dislodged. The replacement of the drain valve corrected the reported issue and no sample will be returned for further evaluation. The device was returned to service. 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 evaluated by the biomedical technician at the complainant's facility.
 
Event Description
It was reported that during therapy, the device leaked from the drain ports. It was confirmed that the fill tube was not stored in the drain port; however, it appeared that the ports were broken. Therapy was interrupted in order to replace the device, and therapy continued with no further issues.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer (Section G)
DYMAX CORP. -2523003
110 marshall drive
warrendale PA 15086
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6445121
MDR Text Key71463637
Report Number1018233-2017-01417
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,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-00-00
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 Received06/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/29/2017 Patient Sequence Number: 1
-
-