• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
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 customer spoke to the biomed and sent in data files showing a failed mixing pump. They discussed both the 2000hour package as well as replacing the part onsite and stated that they would discuss options with the management. They are getting alert 113 (reduced water temperature control) on serial no: (b)(4). Patient temperature was 39. 5c. Water was not going below 30c. Temperature was 4c. Mixing pump command 100%. Pump hours 1434. System hours 1676. Advised to take out of service and send to biomed labeled alert 113, not cooling. They were not sure if they had another device. Per follow up information received via phone on 12jan2022, initial reporter stated that there was no patient harm regarding the issue and was unaware if patient completed therapy on device. The device was sent to biomed and was not aware of the status. They are getting alert 113 (reduced water temperature control) on s/n (b)(4). Patient 39. 5c. Water is not going below 30c. T4 4c. Mixing pump command 100%. Pump hours 1434. System hours 1676. Advised to take out of service and send to biomed labeled alert 113, not cooling. He does not think they have another device. Per follow up information received via phone on 12jan2022, initial reporter stated that there was no patient harm regarding the issue and was unaware if patient completed therapy on device. The device was sent to biomed and was not aware of current status. Per work order update on 13jan2022, it was reported that a functional check showed that the mixing pump had failed.
 
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 customer spoke to the biomed and sent in data files showing a failed mixing pump. They discussed both the 2000hour package as well as replacing the part onsite and stated that they would discuss options with the management. They are getting alert 113 (reduced water temperature control) on serial no: (b)(4). Patient temperature was 39. 5c. Water was not going below 30c. Temperature was 4c. Mixing pump command 100%. Pump hours 1434. System hours 1676. Advised to take out of service and send to biomed labeled alert 113, not cooling. They were not sure if they had another device. Per follow up information received via phone on 12jan2022, initial reporter stated that there was no patient harm regarding the issue and was unaware if patient completed therapy on device. The device was sent to biomed and was not aware of the status. They are getting alert 113 (reduced water temperature control) on s/n (b)(4). Patient 39. 5c. Water is not going below 30c. T4 4c. Mixing pump command 100%. Pump hours 1434. System hours 1676. Advised to take out of service and send to biomed labeled alert 113, not cooling. He does not think they have another device. Per follow up information received via phone on 12jan2022, initial reporter stated that there was no patient harm regarding the issue and was unaware if patient completed therapy on device. The device was sent to biomed and was not aware of current status. Per work order update on 13jan2022, it was reported that a functional check showed that the mixing pump had failed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13392072
MDR Text Key286061563
Report Number1018233-2022-00242
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/31/2022 Patient Sequence Number: 1
-
-