MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, POWER CORD; ARCTIC SUN POWER CORD

Model Number	50000000
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
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.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the respiratory came in while rewarming patient and unplugged arctic sun device from the wall.At some point spark from wall occurred in the room.They were moving patient and device to a new room.Wanted to know how to continue therapy.Targeted temperature (tt) was 37c and patient temperature (pt) was 36.8c.Advised to plug in device in new room.At boot up select continue current patient and start under rewarm where they left off.After spark occurred in other room they moved patient to new room and have plugged in the device to resume therapy.Device would not power on.Advised they would need to send this device to biomed for evaluation.Electrical issue in other room possibly damaged the device.Confirmed they did not have another device available for use.Will need to consult protocol on alternate method for therapy.Biomed call.A nurse plugged in device and it sparked the night before.Biomed had worked on the device and replaced the power cord.They would like to do a functional check and make sure everything was working appropriately.Warm transferred for proper handling.
Event or Problem Description
It was reported that the respiratory came in while rewarming patient and unplugged arctic sun device from the wall.At some point spark from wall occurred in the room.They were moving patient and device to a new room.Wanted to know how to continue therapy.Targeted temperature (tt) was 37c and patient temperature (pt) was 36.8c.Advised to plug in device in new room.At boot up select continue current patient and start under rewarm where they left off.After spark occurred in other room they moved patient to new room and have plugged in the device to resume therapy.Device would not power on.Advised they would need to send this device to biomed for evaluation.Electrical issue in other room possibly damaged the device.Confirmed they did not have another device available for use.Will need to consult protocol on alternate method for therapy.Biomed call.A nurse plugged in device and it sparked the night before.Biomed had worked on the device and replaced the power cord.They would like to do a functional check and make sure everything was working appropriately.Warm transferred for proper handling.Per follow up information received via email on 20jul2023, (see attachment).It was reported that the plug sparked and biomed was called.The cord was replaced, and the device was placed back into service.No additional information or sample is available.No further follow up attempts required.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed power cord.The cord was replaced, and the device was placed back into service.A dhr review is not required as the serial number is unknown.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11: section a through f - the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that the respiratory came in while rewarming patient and unplugged arctic sun device from the wall.At some point spark from wall occurred in the room.They were moving patient and device to a new room.Wanted to know how to continue therapy.Targeted temperature (tt) was 37c and patient temperature (pt) was 36.8c.Advised to plug in device in new room.At boot up select continue current patient and start under rewarm where they left off.After spark occurred in other room they moved patient to new room and have plugged in the device to resume therapy.Device would not power on.Advised they would need to send this device to biomed for evaluation.Electrical issue in other room possibly damaged the device.Confirmed they did not have another device available for use.Will need to consult protocol on alternate method for therapy.Biomed call.A nurse plugged in device and it sparked the night before.Biomed had worked on the device and replaced the power cord.They would like to do a functional check and make sure everything was working appropriately.Warm transferred for proper handling.Per follow up information received via email on 20jul2023, it was reported that the plug sparked and biomed was called.The cord was replaced, and the device was placed back into service.No additional information or sample is available.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, POWER CORD
• Common Device Name: ARCTIC SUN POWER CORD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17263198
• Report Number: 1018233-2023-04874
• Device Sequence Number: 8061917
• Product Code: DWJ
• UDI-Device Identifier: 00801741080258
• UDI-Public: 00801741080258
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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: 50000000
• Device Catalogue Number: 733-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 11/08/2023; 12/14/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 11/22/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown