Agency classClass IOur severity:Severe FDA (Devices)·Z-1577-2016·Announced 2016-05-18

Medtronic Recalls Capnostream 20 Patient Monitor Battery Packs

Medtronic is voluntarily recalling battery packs for the Capnostream 20 and 20p patient monitors because they may experience thermal runaway, posing a potential fire risk.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of…"

Plain-English summary

Medtronic Respiratory & Monitoring Solutions is conducting a voluntary recall of battery packs used with the Capnostream 20 and Capnostream 20p patient monitors. The affected battery packs, identified by product numbers 016400 and 010520, may experience thermal runaway, which creates a potential fire risk to the monitor.

The recall involves 9,817 battery units, including 8,170 units shipped with monitors and 1,647 spare parts. These products were distributed nationwide to 49 states and the District of Columbia, as well as to customers worldwide. The Capnostream 20 and 20p monitors are intended for use by professionally trained healthcare providers to monitor patients in hospitals and transport environments.

Healthcare facilities and consumers should stop using the affected battery packs immediately. Medtronic is the recalling firm and is responsible for managing the recall process.

The recalled product

Product: Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when…
Manufacturer: Medtronic
Category: Medical Device — Patient Monitor Accessories
Hazard: fire
thermal-runaway

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Product # 016400
All SNs
irrespective of production date. Product # 010520
All SNs with production date starting 14.14

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

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