Kimberly-Clark Patient Warming System - Model 100 Control Unit and Energy Transfer Pads

• • Terminated Z-2181-2012 FDA Class II ·initiated 27 Apr 2012

  A defect of the "fuse holder" can lead to a Control Unit failure that may cause the device to lose its ability to warm and maintain set temperature and may also result in excessive heat with the fuse assembly that could lead to the generation of smoke.

• • Terminated Z-0451-2013 FDA Class II ·initiated 16 Sep 2010

  Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.

510(k) Number

K033021 ↗

FDA Product Code

DWJ

Device Class

Class II

Regulation

21 CFR Part 870.5900

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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