The customer reported the following: ¿today we had an issue with an airlife manual resuscitator.The bag had not been used for several days at least.They took the patient off to bag him before a travel, as a test because he was on high support.He had desaturations with manual ventilation.This was repeated several times."the patient only desaturated to about 85%, the therapist was at the bedside troubleshooting and quickly observed the issue and replaced the manual resuscitator." the therapist noticed the exhalation valve looked funny.She removed the peep valve and the exhalation valve fell out onto the floor.The exhalation flapper valve (white disc) folded over and fell out when peep valve attached was removed".They replaced it with a new bag and went on the travel after ensuring stability in the patient.The sample being returned for evaluation will be a companion sample.The resuscitator involved in the incident was disposed of by the customer.
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(b)(4).Follow up emdr with device evaluation summary.The device history record for the reported lot number was evaluated for any issues related with this customer report, and no issues were observed.One representative sample was received for evaluation with a lot number of 0000879588.During our visual inspection no issues were found.Functional inspections were also performed to the unit (pressure/leak test, pull test, solvent effectiveness, and inhalation/exhalation test) and no issues were found with the sample provided.Based on the investigation, at this time the issue reported on this product could not be confirmed.The sample provided was evaluated and did not present any anomalies.At this time no corrective action will be implemented since the issue reported was not confirmed.(b)(4).
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