Device Recall Perseus A500

  • Modelo / Serial
    ASKM-0197 ASKN-0006 ASKN-0007 ASKN-0008 ASKN-0009 ASKN-0013 ASKN-0014 ASKN-0015 ASKN-0021 ASKN-0026 ASKN-0027 ASKN-0028 ASKN-0029 ASKN-0030 ASKN-0031 ASKN-0034 ASKN-0035 ASKN-0036 ASKN-0037 ASKN-0038 ASKN-0039 ASKN-0040 ASKN-0042 ASKN-0045 ASKN-0046 ASKN-0048 ASKN-0049 ASKN-0050 ASKN-0053 ASKN-0054 ASKN-0055 ASLA-0009 ASLA-0010
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
  • Descripción del producto
    Perseus A500 Anesthesia Machine; Cat. no. MK06000 || Product V || Product Usage: || Intended 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.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    ASHB-0140 ASHF-0039 ASHF-0055 ASHF-0056 ASHF-0057 ASHH-0008 ASHH-0009 ASHH-0010 ASHH-0011 ASHH-0012 ASHH-0013 ASHH-0014 ASHJ-0095 ASHJ-0096 ASHJ-0097 ASHJ-0098 ASHJ-0099 ASHK-0001 ASHK-0002 ASHK-0003 ASHK-0008 ASHK-0009 ASHK-0010 ASHK-0056 ASHK-0057 ASHK-0079 ASHK-0080 ASHK-0081 ASHK-0082 ASHK-oo83 ASHK-0084 ASHK-0085 ASHK-0086, and  ASHK-0087.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
  • Descripción del producto
    Perseus A500 Anesthesia Workstation, MK06000. || Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
  • Manufacturer