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Recall Observatory FDA recall evidence

Device product

Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is designed to store and warm blankets and hospital linens in one compartment and fluids (irrigation and/or injection) in the other compartment within the storage times and warming temperatures recommended by the manufacturers of those items

Z-0951-2017

October 15, 2016

Class II

Product summary

Firm
Natus Manufacturing Limited
Event
Event 75846
Status
Terminated
Classification
Class II
Quantity
31
Official record key
device-enforcement:Z-0951-2017

Official wording

Reason: The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.

Code information: Warmette Blanket Cabinet Serial Numbers: 10216709, 10216711, 10218559, 10219214, 10219337, 10219338, 10219339, 10219340, 10219387, 10219388, 10219869, 10219870, 10219871, 10219872, 10219873, 1028880. Warmette Dual Cabinet Serial Numbers: 10216713, 10216714, 10218500, 10218501, 10218522, 10218526, 10218528, 10218982, 10219257, 10219389, 10219390, 10220534, 10220536, 10220537, 10220538.

Distribution pattern: Worldwide Distribution - US including NJ, NC, TX, IL, VA, NY, FL, CA, MS, WA, IN, and MA. and Internationally to Canada and Costa Rica.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The fuse blows during initial power up or after a period of time. This results in a complete loss of power to the Cabinet and in some cases has resulted in the fuse cover for the power inlet melting slightly.