MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, CALIBRATION TEST UNIT; CALIBRATION UNIT

Model Number	74100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the unit was coming back for re-calibration, and the heater harness failed.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that the unit was coming back for re-calibration, and the heater harness failed.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, CALIBRATION TEST UNIT
• Common Device Name: CALIBRATION UNIT
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7876792
• Report Number: 1018233-2018-04181
• Device Sequence Number: 2725848
• Product Code: DWJ
• UDI-Device Identifier: 00801741080418
• UDI-Public: (01)00801741080418
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74100
• Device Catalogue Number: 74100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1