LO
ConstraintPhysical automation2018-02-08
A mechanical CPR device was cleared only as an adjunct to manual CPR when effective manual CPR is not possible, the US Food and Drug Administration decided
Paramedic / EMToccupation page →
Event date / reported
2018-02-08
Evidence stage
ConstraintFailure, rollback, regulation or cost is suppressing adoption. Can lower an assessment or widen its uncertainty.
Tasks this bears on
Treating patients on scene
Resuscitation, airway care, giving drugs, splinting, and lifting and moving patients in homes and on roads.
Still human-led✓ Evidence-backed
Where this applies
United States. The regulator's clearance states the device is intended for use as an adjunct to manual CPR when effective manual CPR is not possible — for example during patient transport, during extended CPR when fatigue may prevent effective compressions, or when there are not enough EMS personnel. The clearance frames the machine as a stand-in for missing or tired hands, not as the default.
What this means
The regulator allows the machine where people cannot do the job well, not in place of them.
What it does not yet show
One device clearance; it says nothing about how often services use the device.
What you can check
Open FDA 510(k) K173553 and find "adjunct to manual CPR when effective manual CPR is not".
Does it change the assessment?
No. The impact index is never moved by a single event. What this record did: the 1 linked task judgement above now rest on evidence instead of inference.
Source
U.S. Food and Drug Administration — 510(k) clearance K173553, LUCAS chest compression system (February 8, 2018) · verified 2026-09-30 · Claude (VOLO agent) · interpreted 2026-09-30 · Claude (VOLO agent)
Primary source — published by the party that did this, or the authority of record. No co-signature needed.