Alerta De Seguridad para 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy

Safety alert

2012-02-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120214a.html

Field safety notice: salter labs 7600 bubble humidifier used with supplemental oxygen therapy the food and drug administration (fda), united states, has issued a class i recall on salter labs 7600 bubble humidifier (350cc volume with 6psi safety valve). the manufacturer of the device, salter labs, found that in certain lots of the 7600 bubble humidifiers, the humidifier lids failed to pop off at the intended pressure. also, when the pop-off does occur, the brass slug does not always reseat to the appropriate position. when the slug fails to reseat properly, the humidifier can leak. for conscious adult patients and in hospital settings with well trained personnel, the leak characteristic of this defect would be obvious. however, for an unconscious, critically ill patient, or for an infant, or child patient, or a home care patient, the leaking may not be obvious to the patient or to the caregiver in a home care situation. a humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. hypoxemia may develop resulting in death or serious adverse health consequences. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm291785.Htm. if you are in possession of the product, please contact your supplier for necessary actions.