MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE

Model Number 50000000E

Device Problem Biocompatibility (2886)

Patient Problems Chills (2191); Discomfort (2330); No Code Available (3191)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient developed pneumonia after developing breathing difficulties overnight.It was also reported that the arctic sun device did not malfunction, but rather made the patient uncomfortable and following the protocol could not ease the patient's discomfort.The patient was removed from the arctic sun device but the patient continued to shiver slightly for the next 48 hours.Warm blankets were applied and the patient was also treated for fever with schedules tylenol.It was also reported that cefepime, vancomycin, tylenol, and fentanyl, were administered for respiratory distress.Therapy was not completed on the device.

Manufacturer Narrative

The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.It was found that the device was working properly.No repairs were made to the device for the reported issue.The control panel coin cell was replaced.It is unknown if the device was influenced by the reported failure, however the device met specifications for the reported issue during evaluation.The device was being used for treatment at the time of the reported event.Bmd investigation indicates that the reported issue was unconfirmed.Therefore the labeling and dhr review is not required.Corrections: d,h h11: section a through f - 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.H3 other text : the actual/suspected device was evaluated.

Event Description

It was reported that the patient developed pneumonia after developing breathing difficulties overnight.It was also reported that the arctic sun device did not malfunction, but rather made the patient uncomfortable and following the protocol could not ease the patient's discomfort.The patient was removed from the arctic sun device but the patient continued to shiver slightly for the next 48 hours.Warm blankets were applied and the patient was also treated for fever with schedules tylenol.It was also reported that cefepime, vancomycin, tylenol, and fentanyl were administered for respiratory distress.Therapy was not completed on the device.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• MDR Report Key: 11050042
• MDR Text Key: 223137294
• Report Number: 1018233-2020-21880
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 81