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

Catalog Number 5000-01-02

Device Problem Electrical Shorting (2926)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was reported that the nurse disconnected the plug from the pendant in an arctic sun device, the nurse received an electric shock and immediately removed their hand away from the plug.The electrician removed the plug and confirmed that there was no fault with the pendant.They believed that this shock was caused when the nurse tried to remove the plug and due to the size and shape of the plug (the thin casing) touched the pins.The plug was cut off by the electrician and disposed off and therefore could not be tested.Per follow up information received via email on 03oct2023, the unit was now back with them and currently waiting to be inspection by the engineer.

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.

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.Upon receipt of the unit, ac lead was found cut.Ac lead was replaced.The reported event is unconfirmed, dhr review is not required.The reported event is unconfirmed, labeling/packaging review is not required.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 actual/suspected device was inspected.

Event Description

It was reported that the nurse disconnected the plug from the pendant in an arctic sun device, the nurse received an electric shock and immediately removed their hand away from the plug.The electrician removed the plug and confirmed that there was no fault with the pendant.They believed that this shock was caused when the nurse tried to remove the plug and due to the size and shape of the plug (the thin casing) touched the pins.The plug was cut off by the electrician and disposed off and therefore could not be tested.Per follow up information received via email on 03oct2023, the unit was now back with them and currently waiting to be inspection by the engineer.Per sample evaluation results on 08dec2023, it was reported that the arctic sun device had intermittent chiller fault.

• 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
• 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: 17939094
• MDR Text Key: 325723649
• Report Number: 1018233-2023-07463
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 5000-01-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 02/10/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other