Device product

3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)

Z-0114-2018

October 17, 2017

Class II

Product summary

Firm: 3M Company - Health Care Business
Event: Event 78327
Status: Terminated
Classification: Class II
Quantity: 153 cases (3825 sensors)
Official record key: device-enforcement:Z-0114-2018

Official wording

Reason: During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.

Code information: Lot Numbers: 17230, Exp. 2020 Aug 18; 17233, Exp. 2020 Aug 21; 17234, Exp. 2020 Aug 22; 17241, Exp. 2020 Aug 29

Distribution pattern: CA, MI, IL, MO, MN, GA, and Canada, Switzerland

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.