Events

Rappel de Device Recall Propaq LT 802LT series Vital Signs Monitor

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 Welch Allyn Protocol, Inc.

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
    66919
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0633-2014
  • Date de mise en oeuvre de l'événement
    2013-11-21
  • Date de publication de l'événement
    2014-01-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124195
  • 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 (Without Arrhythmia Detection Or Alarms) - Product Code MWI
  • Cause
    Welch allyn will update propaq 802 series vital signs monitor, models are 802ltan, 802lton and 802ltr with software because the fault conditions relating to hardware or software failure or electrical noise caused by proximal defibrillation activity could, in rare instances, potentially interrupt device operations.
  • Action
    Welch Allyn began sending out the Urgent Medical Device Correction letter, dated December 03, 2013, to consignees on December 10, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customer Actions: In the unlikely event that operation of your Propaq LT is interrupted and the display becomes blank or white, pressing the power (on/off) button will restart the device and quickly bring it back to full operational capacity. This notice should be passed on to all those who need to be aware within your organization, or to any organization where the potentially affected devices have been transferred. Welch Allyn is in the process of developing a software installation service tool that will enable installation of the software update by your biomed, IT staff or other technically qualified personnel. Upon release, the service tool will be made available to you via a download from Welch Allyn's website at www.welchallyn.com/PropaqltUpgrade or other media. In the meantime and on an on-going basis, the software update will be included if you schedule routine or other service with Welch Allyn or an authorized service provider. Customers with questions were instructed to call Welch Allyn Technical Support at 1-800-535-6663. For questions regarding this recall call 503-530-7935.

Device

Device Recall Propaq LT 802LT series Vital Signs Monitor
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.
  • Description du dispositif
    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. || These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. || intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
  • Manufacturer
    Welch Allyn Protocol, Inc

Manufacturer

Welch Allyn Protocol, Inc
  • Adresse du fabricant
    Welch Allyn Protocol, Inc, 8500 Sw Creekside Pl, Beaverton OR 97008
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA