Events

Recall of DPM 7 PATIENT MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ULTRA-PORTABLE INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    139954
  • Event Risk Class
    I
  • Event Initiated Date
    2014-11-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    An issue has been identified that involves the ibp module used with the dpm 6 and dpm 7 monitor. specifically the ibp measurement data may be displayed in an incorrect ibp tile on the monitor's display (i.E. ibp1 output data may appear in the ibp2 tile and vice versa). if this situation occurs diagnosis may be misguided and contribute to medical treatment being inadvertently rendered or withheld.

Device

DPM 7 PATIENT MONITOR
  • Model / Serial
    Model Catalog: 6800F-PA00001 (Lot serial: >10 Contact mfg); Model Catalog: 6802F-PA00001 (Lot serial: >10 contact mfg)
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Invasive Blood Pressure Module
  • Manufacturer
    ULTRA-PORTABLE INC.

Manufacturer

ULTRA-PORTABLE INC.
  • Manufacturer Address
    VILLE SAINT-LAURENT
  • Source
    HC