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.
What this means for you
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 involves a critical care medical device (ventilator power supply) where a defect (short battery life) poses a risk of harm to patients, particularly during transport, but no injuries or illnesses have been reported.
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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