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IntelliVue CL Respiration Pod

Philips Medizin Systeme Böblingen GmbH · Model IntelliVue CL Respiration Pod · UDI-DI 00884838020689

BZQ Prescription
10
510(k) clearances
127
Adverse events (11 deaths)
3
Recalls
110
Facilities

Description

IntelliVue Cableless Respiration Pod, a battery-powered respiration device for frequent Cableless Monitoring of patients. The IntelliVue CL Respiration Pod provides the respiration rate and optional the pulse rate via short range radio to the receiving system.

Recalls

DateFirmReason
2010-12-21Salter Laboratories, Division of Regulatory AffairsThe 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.
2004-06-04Respironics, Inc.Recalling firm received a product complaint from a customer that the lead wire from Model 915 battery was not connected.
2004-05-24CAS 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.