HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32")
AUGUSTINE TEMPERATURE MANAGEMENT LLC · Model U501 · UDI-DI 00855913001817
Description
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses are available with cables which enable the mattress to function as a capacitive return electrode for electrosurgery for one or two ESUs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down, |
| 2026-07-13 | Gentherm Medical, LLC | Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down. |
| 2025-05-13 | Belmont Instrument LLC | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconne |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-16 | Augustine Temperature Management, LLC | There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the matt |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
| 2024-12-04 | Augustine Temperature Management, LLC | Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test |
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