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 ARCTIC GEL 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 ARCTIC GEL PADS Back to Search Results
Catalog Number UNKNOWN
Device Problems Device Alarm System (1012); Restricted Flow rate (1248); Overheating of Device (1437); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); 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.
 
Event Description
It was reported that the patient's temperature overshot the target temperature to 33c.The device also displayed an alert 02 as well.The nurse disconnected and reconnected the pads and got an alert 07 (water not completely drained).After disconnecting and reconnecting the pads again, the device displayed 0 flow.
 
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be 'poor flow' with a potential root cause of '3.3.1 improper storage causing crushed pad, pad dimples, and/or pad lines.' the lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this arctic gel pad device is unknown.Therefore, bd is unable to determine the associated labeling to review 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 patient's temperature overshot the target temperature to 33c.The device also displayed an alert 02 as well.The nurse disconnected and reconnected the pads and got an alert 07 (water not completely drained).After disconnecting and reconnecting the pads again, the device displayed 0 flow.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCTIC GEL PADS
Type of Device
GEL PAD
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9459940
MDR Text Key176759270
Report Number1018233-2019-07920
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 01/22/2020
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/23/2019
Initial Date FDA Received12/12/2019
Supplement Dates Manufacturer Received01/20/2020
Supplement Dates FDA Received01/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-