Catalog Number MP01920 |
Device Problems
Decrease in Pressure (1490); Inaccurate Delivery (2339); Detachment of Device or Device Component (2907); Gas/Air Leak (2946)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/06/2023 |
Event Type
Death
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Event Description
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It was reported that the tube connected to the oxygen mask came off while using on a palliative care ward.A nurse confirmed that a patient had died.The causal relationship with the tube coming off the mask is unknown.
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
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Manufacturer Narrative
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One packaged and one unpackaged mask was sent by the customer.They showed no deviation.Additionally 20 masks from stock were inspected which showed no deviation as well.The root cause for the reported event is unknown.According to the ifu appropriate monitoring (e.G.Spo2) need to be ensured for the therapeutic effect.In this case no spo2 monitoring was used.Also a safe connection to the o2 mask need to be ensured.The causal correlation with the tube coming off the mask and the patient's death is unknown.
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Event Description
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It was reported that the tube connected to the oxygen mask came off while using on a palliative care ward.A nurse confirmed that a patient had died.The causal relationship with the tube coming off the mask is unknown.
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Search Alerts/Recalls
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