Home Insect Allergies Philips Recollects OmniLab Superior+ Ventilators

Philips Recollects OmniLab Superior+ Ventilators


RT’s Three Key Takeaways:

  • Philips Respironics has issued a recall for its OmniLab Superior+ (OLA+) ventilators because of an alarm failure that may result in remedy interruption or lack of air flow.
  • The FDA classifies this as probably the most severe sort of recall, with 15 accidents and one reported demise.
  • The OLA+ ventilator is utilized in hospitals and sleep laboratories for sufferers with obstructive sleep apnea and different respiration difficulties.

Philips Respironics Inc is updating use directions for OmniLab Superior+ (OLA+) Ventilator because of a failure within the ventilator inoperative alarm, which might trigger remedy interruption or loss. 

Philips will right the affected OLA+ to deal with the air flow inoperative alarm subject with a software program patch. Alternately, Philips will provide a alternative gadget till these affected OLA+ gadgets are corrected.

This recall entails updating directions for utilizing gadgets and doesn’t contain eradicating them from the place they’re used or offered, in accordance with a recall discover from the US Meals and Drug Administration (FDA). The FDA has recognized this recall as probably the most severe sort. There have been 15 reported accidents. There was one report of demise.

The OLA+ Ventilator is used to assist sufferers with obstructive sleep apnea (OSA), respiration difficulties, and blended varieties of apnea. It may be used for kids aged 7 and older who weigh greater than 40 kilos, in addition to for adults weighing greater than 66 kilos. The gadget is designed to be used in hospitals and sleep laboratories.

What to Do

On April 1, Philips Respironics despatched all affected clients an pressing medical gadget recall recommending the next actions:

  • If a ventilator inoperative alarm happens, instantly take away the affected person from the gadget and join them to an alternate supply of air flow, if accessible.
  • As an non-obligatory step/motion, an try to carry out a “exhausting reboot” (compelled gadget restart) that will quickly restore gadget operate, must be taken.
  • Contact Philips for the software program patch to the Air flow Inoperative Alarm subject.
  • Full and return the response type included on this discover.

Purpose for Updates to Use Directions

The gadget might:

  • Enter a ventilator inoperative state (remedy stopped, audible and visible alarms current) after three reboots inside 24 hours.
  • Enter a ventilator inoperative state with no reboot (restart) previous this situation.

These points may end up in remedy interruption or loss, doubtlessly resulting in anxiousness, confusion/disorientation, elevated/decreased respiratory charge (RR), dyspnea, tachycardia (excessive coronary heart charge), irregular chest wall motion, delicate to extreme hypoxemia/low oxygen saturation, hypercarbia/respiratory acidosis, hypoventilation, respiratory failure, or doubtlessly demise in probably the most weak sufferers.

Machine Use

The OLA+ Ventilator helps individuals breathe by offering two completely different stress ranges. This makes it extra comfy for sufferers to obtain respiration help. The gadget additionally has a characteristic referred to as Bi-Flex, which makes it simpler to change from inhaling to respiration out by decreasing stress throughout exhalation. It affords varied modes of remedy, together with:

  • Steady Constructive Airway Stress
  • Spontaneous mode
  • Spontaneous/Timed mode
  • Timed mode
  • Stress Management modes with non-obligatory Bi-Flex or AVAPS (common quantity assured stress help) options, as set by a healthcare skilled.

Affected Product

  • Product Names: OmniLab Superior+ (OLA+) Ventilator
  • Distinctive Machine Identifier (UDI)/Mannequin: See all affected gadgets
  • Lot/Serial Numbers: Class 1 Machine Recall OmniLab Superior (fda.gov)
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