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Catalog Number 8414900 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problems
Apnea (1720); Sedation (2368)
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Event Date 04/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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Because the device is fixed in the patient room and the patient is still in the same room, the doctors currently don¿t want dräger to enter the room.Consequently, a download of the log file could not yet been performed and we were not able to perform a first cause analysis of the incident until today.Within our investigation we try to obtain further necessary information and will inform you about our investigation results in a follow-up report.
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Event Description
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It was reported that the patient was sedated in the context of a meningitis and was monitored by an intracranial pressure sensor.The respirator was functioning properly then suddenly an alarm was generated and the device requested to check for leaks.No more volume was delivered to the patient.Patient who visually does not breathe.Leak test performed while the patient was ventilated with ambu: no leak.Device check performed with a test lung, test ok.Check of the intubation probe, scotch to be on the mark: mark ok, child sucked: ok.Bolus of sedation (hypnovel/sufentanil/ketamine) to be sure that the child does not bite his probe and lets himself ventilate: ok.Aerosol of ventoline made because of doubt about spasticity.Respirator reconnected on the child and was again in apnea.In doubt, patient hoses changed but still the same problem.Respirator removed and child connected to a new respirator.No more problems with the new respirator and the same hoses.Child who does not breathe.Desaturations and necessity to ventilate him with ambu and with oxygen during the device check (less than 30 minutes).Administration of drugs that would not have been applied if there was no problem.Increase of intracranial pressure during the event (because of the sedation bolus).Handling of the intubation probe when this is was actually not necessary.Needed oxygen for two hours after the incident before returning to normal.Unscheduled blood test was performed to check for consequences.Mobilization of 2 nurses, a child care assistant, a medical intern and a senior doctor for one hour before solving the problem.Respirator was switched off.
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Manufacturer Narrative
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The returned error logbook (1), the returned user logbook (2) and the returned device in question (3) were analyzed regarding the reported leakage event.The analysis of the error logbook (1) showed, that no device related errors were documented in the last 2 years.However, the error logbook revealed that the software installed on the device has not been updated for 10 years, although several updates were made available by the manufacturer.The analysis of the user logbook (2) revealed that several 'low minute volume', 'high tidal volume' and 'low airway pressure' alarms were generated audibly and visibly between the start of the intervention and the time of the reported event.These alarms were caused by a leakage.The returned device (3) was tested in the repair shop.Besides some minor damages that do not stay in relation to the reported event a malfunction of the device was not identified during tests according to manufacturer specification.Hence, the exact cause of the leakage at the time of event could not be determined.However it is likely that the leakage was caused by a reversible functional impairment within the patient breathing system that was fixed when the ventilator was exchanged.No entry in the device log file indicates a warmstart.A stop of ventilation without user interaction was not logged.Thus, it cannot be determined why the user observed that no more volume was delivered to the patient.When the device identifies a disturbance of the ventilation e.G.Caused by leakage as reported in this case it alarms visually and acoustically while ventilation is being continued.The device reacted on an internally determined deviation as specified.
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Event Description
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Please refer to the initial-report.
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Search Alerts/Recalls
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