inforMED
MalfunctionBTM

AIRFLOW

Received Aug 27, 2019

Report 1314417-2019-00045 · MDR key 8936827

Device

Generic name

Manual Resuscitator

Model number

AF1140MB-TM5

Lot number

318170

Product problems

  • Incomplete or Missing Packaging

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS RETURNED, AND THE MASK PORT WAS CONFIRMED OUT OF ROUND VIA A VISUAL INSPECTION. THE MASK PORTS ARE 100% INSPECTED DURING ASSEMBLY THEREFORE THIS DEFECT OCCURRED DURING TRANSIT DUE TO PREVIOUS PACKAGING CONFIGURATIONS. THIS PRODUCT IS PRIOR TO A NEW PACKAGING CONFIGURATION WHICH USED A SLIGHTLY LARGER BOX AND NEW PACKAGING METHOD TO PREVENT MASK PORTS FROM DEFORMING.

Description of Event or Problem

THE CUSTOMER ALLEGES THAT "MASK CONNECTION IS OUT OF ROUND." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.