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SleepmateOne Channel Thermistor, Medium (Cable, Interface & 10 sensors

Ambu A/S · Model 814902-000 · UDI-DI 05707480042012

BZQ Prescription

510(k) clearances

127

Adverse events (11 deaths)

Recalls

110

Facilities

Description

Ref. 1439B (Cable, Interface & 10 sencors)

Recalls

Date	Firm	Reason
2010-12-21	Salter Laboratories, Division of Regulatory Affairs	The incorrect length and connector were utilized in lot 110810 of the ThermiSense Alice 5, making the product unusable as it will not interface with the sleep labs equipment.
2004-06-04	Respironics, Inc.	Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24	CAS Medical Systems, Inc.	Device may not alarm for %SpO2 value limit violations if a specific feature is enabled

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.