• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANMINA -SCI SYSTEMS WARMTOUCH SYSTEM, THERMAL REGULATING

  • 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
 

SANMINA -SCI SYSTEMS WARMTOUCH SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 5016000
Device Problems Image Display Error/Artifact (1304); Overheating of Device (1437)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2020
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 device had system error with temperature too high. It was stated that it reached to 58 degrees, and went into over temperature alarm. The device was power cycled, and reset the button sequence to isolate the issue. There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameWARMTOUCH
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
SANMINA -SCI SYSTEMS
km 15.5 no. 29, plant 06
carr. chapala-guadalajara,jal 45640
MX 45640
Manufacturer (Section G)
SANMINA -SCI SYSTEMS
km 15.5 no. 29, plant 06
carr. chapala-guadalajara,jal 45640
MX 45640
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key10714564
MDR Text Key212385644
Report Number3006544299-2020-00415
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-