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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS ARCTIC SUN PADS Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Cardiac Arrest (1762); Death (1802); Hypothermia (1915); Skin Discoloration (2074); Loss of consciousness (2418); Partial thickness (Second Degree) Burn (2694)
Event Date 12/03/2017
Event Type  Injury  
Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
 
Event Description
It was reported an alarm 115 (prolonged water exposure) sounded at 11:00 pm on (b)(6) 2017 during therapy on arctic sun device, (b)(4). The ms&s helpline was called on (b)(6) 2017 at 10:07 am. The facility stated that patient¿s skin was mottled when the alarm sounded, but therapy had been continued. The next time a skin check was done, both legs were blistered and the skin under the chest pads was not blanching and was blistered. Ms&s advised to remove the pads and save them. The pads were removed from the patient on (b)(6) 2017 approximately between 10:00 and noon. During a follow up call it was stated that the patient came to the hospital in full cardiac arrest and was unresponsive for about an hour. The patient was hypothermic and in the rewarming phase of therapy. However, the patient would not warm. It was further stated that there was not any treatment done to the blisters because the family withdrew all care. The patient expired on (b)(6) 2017 at 3:40 pm. The nurse stated that cause of death was related to the post cardiac arrest. The patient had been maxed out on vasopressors.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard 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 bard.
 
Event Description
It was reported an alarm 115 (prolonged water exposure) sounded at 11:00 pm on (b)(6) 2017 during therapy on arctic sun device, sn (b)(4). The ms&s helpline was called on (b)(6) 2017 at 10:07 am. The facility stated that patient¿s skin was mottled when the alarm sounded, but therapy had been continued. The next time a skin check was done, both legs were blistered and the skin under the chest pads was not blanching and was blistered. Ms&s advised to remove the pads and save them. The pads were removed from the patient on (b)(6) 2017 approximately between 10:00 and noon. During a follow up call it was stated that the patient came to the hospital in full cardiac arrest and was unresponsive for about an hour. The patient was hypothermic and in the rewarming phase of therapy. However, the patient would not warm. It was further stated that there was not any treatment done to the blisters because the family withdrew all care. The patient expired on (b)(6) 2017 at 3:40 pm. The nurse stated that cause of death was related to the post cardiac arrest. The patient had been maxed out on vasopressors.
 
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Brand NameARCTICGEL PADS
Type of DeviceARCTIC SUN PADS
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7147902
MDR Text Key285808936
Report Number1018233-2017-06493
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 company representative,other
Type of Report Initial,Followup
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/27/2017 Patient Sequence Number: 1
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