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Model Number 1009-9002-000 |
Device Problem
Gas/Air Leak (2946)
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Patient Problems
Hypoventilation (1916); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Serial number: (b)(4).For 6 of the 6 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.For 1 event, replacement of the bellows and pop-off valve was recommended the customer.
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Event Description
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This report summarizes 6 malfunction events.A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced gas leaks.4 events were reported for a malfunction causing a leak of more than 4.5l per minute affecting ventilation, 2 events reported for a leak resulting in loss of ventilation.These reports were received from various sources.Of the 6 events, 5 did not involve a patient, and 1 did involve a patient.There was no patient information available.
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Event Description
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This report summarizes malfunction events.A review of the events indicated that model 1009-9002-000 anesthesia gas machine experienced gas leaks.3 events were reported for a malfunction causing a leak of more than 4.5l per minute affecting ventilation, 2 events reported for a leak resulting in loss of ventilation.These reports were received from various sources.Of the 6 events, 5 did not involve a patient, and 1 did involve a patient.There was no patient information available.
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Manufacturer Narrative
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Additional information was received that 1 device did not leak more than 4.5l/minute and therefore was not reportable.Serial number (s): (b)(4).For 5 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.Additional information was received that 1 device did not leak more than 4.5l/minute and therefore was not reportable.Serial number: (b)(4).For 5 of the 5 reported events, a ge healthcare service representative performed a checkout of the system and confirmed the reported events.The bag arm hose was replaced to resolve 1 reported event, the adjustable pressure limit valve was replaced to resolve 1 event, the auxiliary common gas outlet output tube #104 was re-connected to resolve 1 event, the condenser e-z tubing was replaced to resolve 1 event, the o-ring at the co2 absorber connection to the circuit was replaced to resolve 1 event.
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Search Alerts/Recalls
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