Model Number 301-MRIPEEP-A |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 11/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.
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Event Description
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Upon disconnecting pt from vent and manually bagging to icu.Within first couple breaths manually delivered, noticed peep valve was not making standard noise.Upon further assessment notice pts chest kept rising but not falling.Quickly disconnected from et tube and noted a huge rush of air released from et tube.One more time i reconnected bag and delivered two more breaths noting again no true exhale from pt/bag.Disconnected again and rush of air noted again.Quickly had pt returned to room and placed back on vent.Acquired new ambu bag and peep valve.New equipment worked properly and pt was safely delivered to new unit.
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Event Description
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Upon disconnecting pt from vent and manually bagging to icu.Within first couple breaths manually delivered, noticed peep valve was not making standard noise.Upon further assessment notice pts chest kept rising but not falling.Quickly disconnected from et tube and noted a huge rush of air released from et tube.One more time i reconnected bag and delivered two more breaths noting again no true exhale from pt/bag.Disconnected again and rush of air noted again.Quickly had pt returned to room and placed back on vent.Acquired new ambu bag and peep valve.New equipment worked properly and pt was safely delivered to new unit.
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Manufacturer Narrative
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The resuscitation bag was being used with the peep valve that could have been blocked, which would have delayed treatment.The complaint of "peep valve not making standard noise.Pt not fully exhaling." regarding part 301-mripeep-a was not confirmed because functional testing indicated that the device formed as intended.The root cause cannot be determined but could possibly be a result of an issue with the resus bag that was used.A risk assessment was performed and the ultimate risk was determined to be low which does not require the initiation of a capa.There have been no other complaints against this part in the 24 months preceding this complaint.A resolution letter was sent to the customer.
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Search Alerts/Recalls
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