MAUDE Adverse Event Report: MEDIVANCE ARTIC SUN MODEL 5000 TEMPERATURE MANAGEMENT SYSTEM

Catalog Number 5000-01-01

Device Problems Carbon absorption (1082); Circuit Failure (1089)

Patient Problem Death (1802)

Event Date 07/18/2014

Event Type  Death  

Event Description

It was reported the device was in use when the circuit failure, alarm 78, occurred.The facility reported that the patient passed away after an unknown length of time after the machine malfunctioned.A supplemental mdr will be filed if additional information becomes available.

Manufacturer Narrative

No samples will be returned for evaluation.Device was serviced by (b)(4).The reported event could not be confirmed by (b)(4).The device was not duplicated.A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The finished product met all specifications prior to being released for general distribution.(b)(4).

• Brand Name: ARTIC SUN MODEL 5000 TEMPERATURE MANAGEMENT SYSTEM
• Manufacturer (Section D): MEDIVANCE; louisville CO
• Manufacturer (Section G): MEDIVANCE; 321 south taylor ave.; suite 200; louisville CO 80027
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4101405
• MDR Text Key: 4715274
• Report Number: 1018233-2014-00228
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K101092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death