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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CELSIUS MEDICAL S.L. WARMTOUCH SYSTEM, THERMAL REGULATING

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CELSIUS MEDICAL S.L. WARMTOUCH SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5016000
Device Problem Device Alarm System (1012)
Patient Problem No Patient Involvement (2645)
Event Date 01/17/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the unit alarm did not occurred. There was no patient involvement.
 
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Brand NameWARMTOUCH
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
CELSIUS MEDICAL S.L.
ctra de ajalvir, km 5, 200
ajalvir 28864
ES 28864
Manufacturer (Section G)
CELSIUS MEDICAL S.L.
ctra de ajalvir, km 5, 200
ajalvir 28864
ES 28864
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key9647692
MDR Text Key176997329
Report Number2936999-2020-00067
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K123083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5016000
Device Catalogue Number5016000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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