Device Problems
Device Alarm System (1012); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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A follow-up report will be submitted upon completion of this investigation.
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Event Description
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It was reported that 2-3 hours with baby saturation wasn't good, no alarm, no more oxygen.
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Manufacturer Narrative
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It was clarified that no adverse patient impact was reported.The reported failure to alarm for no oxygen on the resuscitaire could not be verified during the evaluation performed by the draeger technician by phone with the hospital respiratory therapist on site, the device alarmed accordingly.No malfunctions were identified and no parts were replaced.No further issues have been reported.This is an isolated case.The resuscitiare instructions for use provides the following: warning monitor the concentration of oxygen provided and the partial pressure of oxygen in the patient blood (pao2).Failure to do so could result in patient injury.Warning do not leave the patient unattended when using the autobreath resuscitation module.Patient injury could occur.Warning frequently assess the patient and monitor any alarm conditions.Failure to do so could result in patient injury.Patient monitoring - the user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition.Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs.The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.
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Event Description
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It was reported that 2-3 hours with baby saturation wasn't good, no alarm, no more oxygen.
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Search Alerts/Recalls
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