The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging water entered the lungs resulting in pneumonia.The patient was seen by a the doctor who took x-rays and the patient was diagnosed with pneumonia.The patient's current condition was described as okay, but the patient had a cough.The device settings at the time of the alleged incident was 12cm (centimeters of water pressure).The cleaning method the patient used was rinsing the device with water and mild detergent, then rinsed the device again and dried completely.This method of cleaning was performed daily.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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The manufacturer previously reported information in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging water entered the lungs resulting in pneumonia.The patient was seen by a the doctor who took x-rays and the patient was diagnosed with pneumonia.The patient's current condition was described as okay, but the patient had a cough.The device settings at the time of the alleged incident was 12cm (centimeters of water pressure).The cleaning method the patient used was rinsing the device with water and mild detergent, then rinsed the device again and dried completely.This method of cleaning was performed daily.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Correction/update: the manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging the water was draining too quickly and was causing the patient to choke at times.The patient reported water entered the lungs resulting in pneumonia.The patient was seen by a the doctor who took x-rays and the patient was diagnosed with pneumonia.The patient's current condition was described as okay, but the patient had a cough.The device settings at the time of the alleged incident was 12cm (centimeters of water pressure).The cleaning method the patient used was rinsing the device with water and mild detergent, then rinsed the device again and dried completely.This method of cleaning was performed daily.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Please note (the following updates were performed): section b: adverse event/product problem: changed to' product problem'.Removed selection for outcomes attributed to ae since complaint was assessed as non-serious.Section h: type of reported complaint: changed to 'product problem'.Section h: patient outcome code grid: additional patient outcome code added - choking.Section h: health impact grid: changed to 'no health consequences or impact'.
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