PFR95 PART FILT RESP

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. ACCORDING TO THE DEVICE HISTORY RECORDS (DHR) THE PRODUCT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES AND SPECIFICATIONS. THE PRODUCT WAS RELEASED BY QUALITY ASSURANCE. A QUALITY NONCONFORMANCE WAS NOT REPORTED AT THE TIME OF PRODUCTION. AT THE TIME OF THE DHR REVIEW, THE RESULTS OF THE PULL STRENGTH TEST FOR HEADSTRAP AVERAGE 7 LBS. PERFORMANCE THROUGHOUT MANUFACTURE OF THE PRODUCT (THIS IS WITHIN SPECIFICATIONS). A ROOT CAUSE WAS NOT DETERMINED. NOTIFICATION WAS SENT TO MANUFACTURING LEADERS FOR AWARENESS. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3: OTHER TEXT : DEVICE NOT RETURNED.

Description of Event or Problem

THE BAND PULLED AWAY FROM THE MASK (IN A COVID ROOM). A LEVEL ONE COVER WAS OVER THE TOP TO HOLD THE MASK IN PLACE. THERE HAVE BEEN OTHER INSTANCES WHERE THE BANDS BROKE TRYING TO PUT ON MASK OR BROKE AFTER THEY PUT THE MASK ON. THE FOLLOWING MEDICAL DEVICE REPORT IS BEING FILED RETROACTIVE TO PRIOR DECISION THAT THIS MALFUNCTION WOULD BE UNLIKELY TO RESULT IN A SERIOUS INJURY OR ILLNESS. A REASSESSMENT OF THIS INCIDENT HAS SINCE FOUND THAT SHOULD THIS MALFUNCTION RECUR IN AN ISOLATION SETTING OR DURING DIRECT PATIENT CARE, THE END USER MAY CONTRACT COVID VIRUS AND THUS BE SUSCEPTIBLE TO A SERIOUS ILLNESS. FOR THIS REASON THIS INCIDENT IS BEING REPORTED AS A MALFUNCTION AT THIS TIME.