Agency classClass IIOur severity:High FDA (Devices)·Z-1844-2014·Announced 2014-07-02

Puritan Bennett 840 Ventilator Recall for Display Loss

Nellcor Puritan Bennett is recalling 104 Puritan Bennett 840 Ventilators due to reports of loss of graphical user interface display information while the device continues to provide breath support.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a critical life-support device where a display failure could compromise patient monitoring, fitting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nellcor Puritan Bennett Inc. (dba Covidien LP) is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators. The recall involves 104 units distributed worldwide, including the United States and numerous international countries. The affected devices are intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.

The recall is being conducted due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support. The specific units affected are identified by serial numbers 3510100714 to 3512101160, as well as any units in which a replacement power supply unit (PSU) was installed between March 2010 and September 2010.

Healthcare facilities and users should contact the recalling firm to determine if their specific units are affected and to arrange for the field correction. The agency has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in…
Manufacturer: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Category: Medical Device — Ventilator
Hazard: display-failure
monitoring-loss
Affected units: 104

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)

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Same hazard · display failure