Events

Retiro De Equipo (Recall) de Device Recall Welch Allyn PIC 50

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por MRL, Inc., A Welch Allyn Company.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    35688
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1195-06
  • Fecha de inicio del evento
    2006-06-30
  • Fecha de publicación del evento
    2006-07-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46623
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Defibrillator - Product Code MJK
  • Causa
    The welch allyn pic 50 defibrillators may display a 'defib comm' or 'pace comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ecg and deliver the appropriate therapy.
  • Acción
    MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.

Device

Device Recall Welch Allyn PIC 50
  • Modelo / Serial
    Part numbers 971081, 971082, 971083 and 971084; serial numbers 80104, 80119, 80120, 80204, 80211, 80212, 80429, 80432, 80569, 80627, 80661, 80685, 80880, 80964, 81056, 81134, 81263, 81293/81295, 81303, 81445/ 81448, 81733, 81738, 81739, 81744/81752, 81757, 81761/81781, 81802/81807, 81824, 81825, 81835, 81845, 81846, 81852, 81864, 81865, 81868, 81869, 81884/81886, 81892/81897, 81918/81955, 81957, 81983/81990, 81996/82025, 82027/82033, 82035/82039, 82043, 82044, 82061/82080, 82084, 82097/82111, 82122/82128, 82133, 82136/82143, 82150/82169, 82172/82204, 82245, 82252/82273, 82283/82286, 82307/82330, 82340/82349, 82405/82426, 82430, 82460/82490, 82498/82553, 82555/82565, 82568/82570, 82612/82631, 82654/82673, 82689, 82690, 82773/82813, 82827/82830, 82852, 82856/82859, 82906, 82936, 82937, 82958/82977, 82983/83013, 83060/83071, 83083/83090, 83093, 83142/83147, 83153/83172, 83198/83239, 83255, 83368/83370, 83400/83407, 83414/83418, 83420/83429, 83440/83443, 83499/83517, 83578/83580, 83633, 83644, 83645, 83654, 85001/85005, 85009/85013, 85026/85029, 85032/85052, 85073/85079, 85093, 85094, 85110, 85111, 85143/85157, 85187/85201, 85223, 85224, 85226/85238, 85244/85249, 85329, 85332/85334, 85337/85350, 85364, 85365, 85368/85370, 85381, 85388/85398, 85402/85404, 85410/85414, 85420/85433, 85441, 85505/85515, 85517/85520, 85522/85530, 85534, 85552, 85554/85557, 85587/85589, 85602/85607, 85619/85623, 85630, 85645/85655, 85658/85667, 85686, 85728/85734, 85755/85757, 85761/85766, 85771/85785, 85787/85793, 85810, 85812/85823, 85825/85838, 85856/85872, 85877/85884, 85888/85902, 85931/85933, 85945, 85955, 85964, 85967/85970, 86017, 86018, 86024/86029, 86055/86057, 86103, 86104, 86118, 86141/86147, 86149, 86150, 86222/86228, 86230, 86245, 86256/86258, 86261/86268, 86281/86283, 86289/86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320/86322, 86324/86328, 86334, 86335, 86358, 86359, 86385, 86387, 86389/86399, 86400, 86411, 86412, 86419, 86420, 86439, 86440
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United Kingdom and Vietnam.
  • Descripción del producto
    Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • Dirección del fabricante
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA