Events

Rappel de Portable patient monitor with arrhythmia detection or alarms.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56806
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3036-2011
  • Date de mise en oeuvre de l'événement
    2010-09-17
  • Date de publication de l'événement
    2011-08-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94553
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. cause is a software problem.
  • Action
    Spacelabs Medical sent an "URGENT - MEDICAL DEVICE CORRECTION" notification letter to U.S. consignees by mail on September 17, 2010 and to international consignees by e-mail on September 24, 2010. The letter identified the recalled product, warns customers of the potential hazard and identifies some ways to mitigate the risk if they decide to continue use. The letter states to correct this situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to install a free software update. If customers have any questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.

Device

Portable patient monitor with arrhythmia detection or alarms.
  • Modèle / numéro de série
    SERIAL NUMBERS: 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 1367-000112, 1367-000113, 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  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.
  • Description du dispositif
    Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. || Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA