MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR; CABLE TEMP PROBE

Model Number 50000000E

Device Problems Display or Visual Feedback Problem (1184); Device Sensing Problem (2917)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device received alerts 14 and 50.

Event Description

It was reported that the device received alerts 14 and 50.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was a defective temperature cable.Per additional information received, the temperature cable was exchanged and the alerts disappeared.The biomedical technician noted that there was patient involvement, and the patient was placed on a second device, where therapy was completed.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warnings and cautions warnings ¿ do not use the arctic sun® temperature management system in the presence of flammable agents because an explosion and/or fire may result.¿ do not use high frequency surgical instruments or endocardial catheters while the arctic sun® temperature management system is in use.¿ there is a risk of electrical shock and hazardous moving parts.There are no user serviceable parts inside.Do not remove covers.Refer servicing to qualified personnel.¿ power cord has a hospital grade plug.Grounding reliability can only be achieved when connected to an equivalent receptacle marked ¿hospital use¿ or ¿hospital grade¿.¿ when using the arctic sun® temperature management system, note that all other thermal conductive systems, such as water blankets and water gels, in use while warming or cooling with the arctic sun® temperature management system may actually alter or interfere with patient temperature control.¿ do not place arcticgel¿ pads over transdermal medication patches as warming can increase drug delivery, resulting in possible harm to the patient.¿ the arctic sun® temperature management system is not intended for use in the operating room environment.Cautions ¿ this product is to be used by or under the supervision of trained, qualified medical personnel.¿ federal law (usa) restricts this device to sale, by or on the order of a physician.¿ use only sterile water.The use of other fluids will damage the arctic sun® temperature management system.¿ when moving the arctic sun® temperature management system always use the handle to lift the controller over an obstacle to avoid over balancing.¿ the patient¿s bed surface should be located between 30 and 60 inches (75 cm and 150 cm) above the floor to ensure proper flow and minimize risk of leaks.".

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Type of Device: CABLE TEMP PROBE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8537279
• MDR Text Key: 142739250
• Report Number: 1018233-2019-02067
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 735-02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1