Reported Jun 27, 2018 · Terminated
Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults,…
Draeger Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Draeger Medical, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Perseus A500 Anesthesia Machine; Cat. no
- MK06000 Product V Product UsageIntended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system. Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents. Ventilation is accomplished on the patient through a laryngeal mask airway, a full-face mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional). Perseus is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions
- Lot codes and dates
ASKM-0197ASKN-0006ASKN-0007ASKN-0008ASKN-0009ASKN-0013ASKN-0014ASKN-0015ASKN-0021ASKN-0026ASKN-0027ASKN-0028ASKN-0029ASKN-0030ASKN-0031ASKN-0034ASKN-0035ASKN-0036ASKN-0037ASKN-0038ASKN-0039ASKN-0040ASKN-0042ASKN-0045ASKN-0046ASKN-0048ASKN-0049ASKN-0050ASKN-0053ASKN-0054ASKN-0055ASLA-0009ASLA-0010
- Amount recalled
- 33
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
This product could cause temporary or reversible health problems — stop using it.
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