Spacelabs Ultraview SL Capnography

Documents & Manuals

• Spacelabs Ultraview Capnography Specs.pdfDocument · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

• RECALL

  There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.

• RECALL

  Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.

• RECALL

  Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.

• RECALL

  Telemetry Modules are failing to alarm for low heart rate and asystole.

• RECALL

  During battery insertion there is potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes.

• RECALL

  Inaccurate partial pressure readings; readings are not compensated for ambient pressure in mmHg or kPa.

• RECALL

  Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.

• RECALL

  The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.

• RECALL

  Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.

• RECALL

  Potential for telemetry channels to drop off display.