The manufacturer received information alleging a ventilator was alarming for a "circuit disconnect" condition, although the circuit was not disconnected.The patient's respiratory rate dropped to 7 breaths per minute.The patient was taken to the emergency room where she was admitted for pneumonia.The patient has since been discharged from the hospital.The patient was reportedly on the same ventilator for 24 hours prior to being discharged from the hospital and the device functioned without issue.The ventilator was returned to the manufacturer's service center for evaluation.The ventilator passed all testing and was found to operate and alarm, as designed.Although "high pip" and "patient disconnect" alarms were observed in the ventilator's downloaded error log on the date of the alleged event, no malfunction of the device was observed.
|