Tag Archives: Medical Device Safety and Recalls

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

Medical Device Safety and Recalls: eVent Medical LS, 5i, or 7i Inspiration Ventilators May Shut Down without Alarm

A recall has been issued for eVent Medical LS, 5i, or 7i Inspiration Ventilators. eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. The company has received one report of this issue occurring, with no injuries and no deaths. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm475862.htm

Medical Device Safety and Recalls: Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication

Medical Device Safety and Recalls: Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication

A safety communication has been posted titled, “Lubricious Coating Separation from Intravascular Medical Devices

The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors, ranging from the difficulty of the procedure and the patient’s anatomy to practitioner technique or using the wrong device for the procedure, to improper preconditioning of the device and improper storage conditions as well as issues with device design or manufacturing processes.

This communication contains important information physicians should consider to reduce the potential of adverse events. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, health care providers should be aware of potential problems and consider certain actions prior to use.

Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Medical Device Safety and Recalls: FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication

Today, the FDA issued the Safety Communication, “FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods
to notify health care professionals about our concerns with the safety and effectiveness of all Custom Ultrasonics’ AER models. This communication provides recommended actions health care facilities should take if they use Custom Ultrasonics’ AERs because of the risk of transmission of infectious organisms to patients.

Medical Device Safety and Recalls: Insulet Corporation, OmniPod Insulin Management System

Medical Device Safety and Recalls: Insulet Corporation, OmniPod Insulin Management System May Fail to Deliver Insulin

A recall has been issued for the Insulet Corporation’s OmniPod Insulin Management System. Insulet has identified two issues with these devices.

  1. The tube either fails to fully insert into the skin or completely retracts after insertion. This failure occurs without an alarm and the Pod will continue to pump insulin.
  2. The Pod will provide an audible alarm signal and display a failure. Once the alarm occurs, the Pod will not pump insulin.

Both failures can result in inaccurate dosage of insulin which can lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death.

The firm has received nine reports in which the device has malfunctioned, including five injuries and no reports of deaths.

Source: FDA.GOV