Draeger Recalls Optional PS500 Power Supply Units for Ventilators
Draeger Medical is recalling 2,422 optional PS500 power supply units for Evita V500 and Babylog VN500 ventilators due to unexpectedly short battery run times.
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: "The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm…"
Plain-English summary
Draeger Medical, Inc. is recalling 2,422 optional PS500 Power Supply Units intended for use with the Evita V500 Ventilator and Babylog VN500 Ventilator. The Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. The affected units were distributed nationwide, including DC, Puerto Rico, and all 50 states, between June 2011 and October 2015. The catalog numbers for the recalled units are 8416400 and 8417400.
The recall was initiated because the firm became aware of cases where the battery run times of the optional PS500 power supply unit, when used with the Infinity Workstation Critical Care (Evita Infinity V 500), were unexpectedly short. This issue is attributed to the design of the charging algorithm in the current software. Devices used for patient transport are identified as a priority for this recall.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No illnesses, injuries, or deaths are reported in the source text.
The recalled product
- Product
- Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
- Manufacturer
- Draeger Medical, Inc.
- Affected units
- 2,422
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)
- Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.
Distribution
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