MEDLINE

Description of Event or Problem

ACCORDING TO THE FACILITY ON (B)(6) 2025, IT WAS REPORTED THAT A MEDLINE ADJUSTABLE 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 INTERNAL SPRING 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.

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6) 2025, IT WAS REPORTED THAT A MEDLINE ADJUSTABLE 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 INTERNAL SPRING 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 CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.