MEDLINE

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PEEP VALVE USED DURING IPV AIRWAY CLEARANCE THERAPY DID NOT MAINTAIN THE INTENDED PEEP AFTER ONE TO TWO TREATMENT CYCLES. THE PATIENT WAS RECEIVING IPV EVERY FOUR HOURS IN THE PCICU. STAFF NOTED THAT THE FLOW AND PEEP OUTPUT DID NOT SOUND APPROPRIATE. UPON INSPECTION, THE RESPIRATORY THERAPIST FOUND THAT THE INTERNALSPRING OF THE PEEP VALVE WAS LOOSE AND THE ADJUSTMENT KNOB ROTATED TOO FREELY, INDICATING THE DEVICE WAS UNABLE TO HOLD PRESSURE AS INTENDED. THE INABILITY TO MAINTAIN PEEP DURING TREATMENT RESULTED IN DE-RECRUITMENT AND THERAPY WAS CHANGED TO AN ALTERNATIVE MODALITY THAT DID NOT RELY ON PEEP. THE PATIENT DEMONSTRATED IMPROVEMENT FOLLOWING THIS CHANGE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

PEEP VALVE AND THE INTERVAL SPRING WAS LOOSE.