Catalog Number 8414900 |
Device Problems
Use of Incorrect Control/Treatment Settings (1126); Gas Output Problem (1266); Increase in Pressure (1491); Unexpected Therapeutic Results (1631)
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Patient Problem
Pneumothorax (2012)
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Event Date 10/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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The investigation was started; the results will be provided in a follow-up report.
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Event Description
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It was reported, that the "ventilator delivered excessive pressure causing barotrauma to the patient with pneumothorax plus concern that patient may have sustained a stroke as a consequence.Patient subsequently had a cardiac arrest from which they were resuscitated within 2 minutes of commencing cpr.The patient was disconnected from the ventilator and hand ventilated.A chest x-ray revealed a pneumothorax and an intercostal drain was inserted.When patient was noted not to be moving left hand side, he was transferred for a ct.Ct did not reveal a stroke but may have been performed too early.".
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Manufacturer Narrative
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The affected device was tested onsite by a 3rd party technician as well as a dräger service technician and the logfile was provided for further investigation at the manufacturer¿s site.Based on the logfile analysis the reported event could be verified, however, a device malfunction could not be confirmed.The logged entries indicate that there was a large leak which was alarmed by the device.Furthermore, the device reacted as specified in order to compensate this leak within the user¿s settings and generated corresponding alarms when set alarm limits regarding flow and pressure were met.The device-specific instructions for use contains a warning that alarm limits have to be set according to the current patient¿s therapy requirements.Otherwise, the patient may be at risk.The instructions for use also provide information regarding leakage compensation.The electrical emergency valve limited the maximum airway pressure to the set alarm limit.A positive expiratory airway pressure (including peep) was maintained all the time and the peep-level was not below 2.9 mbar during the relevant period of time.Based on the device tests according to the manufacturer¿s specification there was no technical failure found.The internal pressure measurement system was additionally subjected to a comparative measurement using an external pressure meter (fluke) under calibrated conditions.As result of this measurement it could be shown that the internal pressure measurement system was in compliance with the external pressure measurement system within a tolerance of less than 0.5 mbar.Based on the investigation it could be concluded that the device reacted as specified in order to compensate a leak in the airway system.Appropriate alarms were generated according to the user¿s settings in order to alert the user of the situation.There was no device failure found.The number of similar cases, related to the same issue, is within the expected range of the respective risk assessment and thus accepted.
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Event Description
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It was reported, that the "ventilator delivered excessive pressure causing barotrauma to the patient with pneumothorax plus concern that patient may have sustained a stroke as a consequence.Patient subsequently had a cardiac arrest from which they were resuscitated within 2 minutes of commencing cpr.The patient was disconnected from the ventilator and hand ventilated.A chest x-ray revealed a pneumothorax and an intercostal drain was inserted.When patient was noted not to be moving left hand side, he was transferred for a ct.Ct did not reveal a stroke but may have been performed too early.".
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Search Alerts/Recalls
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