MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC SUN DEVICE

Model Number 50000000

Device Problems Gas/Air Leak (2946); No Flow (2991)

Patient Problem 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.The device was not returned.

Event Description

It was reported that the arctic sun device had no flow.The user had changed the arctic sun device and now device was getting air leak.The user had disconnected and reconnected all the connections then the flow rose to 2 l/m.The current arctic sun device with sn (b)(4) was a loaner unit per service max.The user had sent the first arctic sun device to biomed already.

Manufacturer Narrative

Per additional information received, bd has determined that this is not a reportable event.Correction: d1, d4, g5.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the arctic sun device had no flow.The user had changed the arctic sun device and now device was getting air leak.The user had disconnected and reconnected all the connections then the flow rose to 2 l/m.The current arctic sun device with sn (b)(6) was a loaner unit per service max.The user had sent the first arctic sun device to biomed already.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10589987
• MDR Text Key: 209145454
• Report Number: 1018233-2020-06221
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1