Model Number 8607000 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility did not involve the local dräger s&s organization into examination of the device and potential repair measures.The only further detail that could be obtained is that the device is back in use after exchange of the ventilator motor.A case-specific evaluation is not possible for dräger due to lack of information.There was no s/n transmitted; age of the device and status of repairs and preventive maintenance are unknown to dräger.It is plausible that a sudden occurring issue with the ventilator unit would lead to shut-down of automatic ventilation, the exact mechanism of fault can however not be determined.It cannot be excluded that lack of preventive maintenance has led to the reported event.A shut down of ventilation is accompanied by a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible then.H3 other text : device not available for evaluation.
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Event Description
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It was reported that a ventilator failure occurred during use.As per report, the device posted a corresponding alarm.There was no detail in the report which may reasonably suggest that patient consequences were resulting from the event.
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Manufacturer Narrative
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This is a correction of the previous report.The model no.Was corrected.The serial number of the affected fabius gs premium was requested but not provided by the customer.Therefore, the unique device identifier (udi) cannot be determined.
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Event Description
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It was reported that a ventilator failure occurred during use.As per report, the device posted a corresponding alarm.There was no detail in the report which may reasonably suggest that patient consequences were resulting from the event.
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Search Alerts/Recalls
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