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: 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
 

UNKNOWN ARCTICGEL PADS Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/03/2021
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 low air leak.Flow rate was 0.5lpm with 1 pad.The patient had been on for more than 48 hours, no problems until now.The nurse was disconnected and reconnected the pads.The nurse could not get the pad to insert into the hole and explained that the cleared clip broke off.Nurse asked to save that pad and replaced the pad.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be received connectors damaged by supplier.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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 device was not returned.
 
Event Description
It was reported that the arctic sun device had low air leak.Flow rate was 0.5lpm with 1 pad.The patient had been on for more than 48 hours, no problems until now.The nurse was disconnected and reconnected the pads.The nurse could not get the pad to insert into the hole and explained that the cleared clip broke off.Nurse asked to save that pad and replaced the pad.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
UNKNOWN ARCTICGEL PAD
MDR Report Key12235592
MDR Text Key263931465
Report Number1018233-2021-04554
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 10/11/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/03/2021
Initial Date FDA Received07/27/2021
Supplement Dates Manufacturer Received10/12/2021
Supplement Dates FDA Received10/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
-
-