Model Number 1006-9320-000 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Pulmonary Edema (2020)
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Event Date 05/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Weight, ethnicity, race: not available.Device evaluation anticipated, but not yet begun.
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Event Description
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The hospital reported the adjustable pressure limit (apl) valve stuck open during a case causing high positive end-expiratory pressure (peep).The case was completed in bag mode, with the clinician removing the bag to relieve pressure build-up.Subsequently, the patient was extubated earlier than planned.It was reported that the patient suffered pulmonary edema and laryngospasm and was admitted to the med surg floor on bi-level positive airway pressure.The patient was later discharged with no injury.
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Manufacturer Narrative
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Ge healthcare product engineering performed an investigation of this event.The high peep phenomenon could not be reproduced on site and there is no evidence showing the aestiva 7100 had any internal failures.Based on the information from the complaint and the customer questionnaire, the root cause cannot be determined.H3 other text : ge healthcare product engineering performed an investigation of this event.The high peep phenomenon could not be reproduced on site and there is no evidence showing the aestiva 7100 had any internal failures.Based on the information from the complaint and the customer questionnaire, the root cause cannot be determined.
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Search Alerts/Recalls
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