Ventilator Audible and Visual Alarms May Not Activate During Alarm States
The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.
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: FDA Class I classification requires a minimum severity score of 4. The defect involves failure of critical safety alarms on life-support equipment, with potential for serious respiratory and cardiac complications.
Plain-English summary
The Puritan Bennett 980 Series Ventilator, manufactured by Medtronic (formerly Covidien), is being recalled due to a defect in its alarm system. The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states.
When the alarms fail to activate, patients and medical staff may experience delayed awareness of critical conditions. This delay can result in delayed treatment response, potentially causing serious complications including hypoxia, dyspnea, cardiac arrest, or death.
Patients and healthcare providers using affected ventilators should contact Medtronic for instructions on how to proceed. The FDA has classified this as a Class I recall, the most serious category.
The recalled product
- Product
- Puritan Bennett 980 Series Ventilator
- Manufacturer
- Medtronic formerly Covidien
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 (1)
- Lot/Serial Number
Distribution
Distributed nationwide across the United States.
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