Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 UNKNOWN ARCTICGEL PADS
  • 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 UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problems Insufficient Heating (1287); Use of Device Problem (1670)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/11/2023
Event Type  malfunction  
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.
 
Event Description
It was reported that water temperature was not rise in arctic sun device on returned to temperature.
 
Event Description
It was reported that water temperature was not rise in arctic sun device on returned to temperature.Per follow up information received via email on 02aug2023, updated entry description they confirmed device was sent to bd-approved facility for evaluation.They confirmed the issue was resolved.They confirmed the repair was done.They did not get information about the patient.The case completed with replacement machine.No patient impact and no medical intervention required.Per sample evaluation results on 28sep2023, it was reported that the control panel would not boot up.
 
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 confirmed.The root cause was isolated to use of pads with kinked lines.The device was evaluated, and the reported issue was confirmed as it was noted there were kinked lines in the pads which caused low flow leading to the insufficient heating.The kink was unkinked to resolve the issue.A dhr review is not required as the serial number is unknown.The product catalog number and lot number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.Correction: d,f,h 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 water temperature was not rise in arctic sun device on returned to temperature.Per follow up information received via email on (b)(6) 2023, they confirmed device was sent to bd-approved facility for evaluation.They confirmed the issue was resolved.They confirmed the repair was done.They did not get information about the patient.The case completed with replacement machine.No patient impact and no medical intervention required.Per sample evaluation results on (b)(6) 2023, it was reported that the control panel would not boot up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PADS
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 Key17404765
MDR Text Key320664160
Report Number1018233-2023-05525
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-