MAUDE Adverse Event Report: DYMAX CORP. -2523003 ARTIC SUN MODEL 5000 TEMPERATURE MANAGEMENT SYSTEM; ARCTIC SUN DEVICE

Catalog Number 5000-00-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Alteration In Body Temperature (2682)

Event Type  malfunction  

Event Description

It was reported that the patient developed skin blisters under the pads while the machine was in use.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation the lot number is unknown; therefore, the device history record could not be reviewed.

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.

Manufacturer Narrative

The serial number for the device associated with this particular event could not be identified by the complainant; however, the following serial numbers ((b)(4)) that were in use at the time this event occurred underwent a manufacturing review during the investigation process.The device history records were reviewed and found nothing that could have caused or contributed to the reported event.Corrections: common device name, mfr name, city, and state, model/lot #, user facility or importer, manufacturer site, pma #.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.

• Brand Name: ARTIC SUN MODEL 5000 TEMPERATURE MANAGEMENT SYSTEM
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; 1725056; warrendale PA 15086
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4360295
• MDR Text Key: 5117248
• Report Number: 1018233-2014-00359
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5000-00-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention