PFR95 PART FILT RESP

Additional Manufacturer Narrative

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORDS (DHR) EVALUATION WAS PERFORMED FOR THE PRODUCT CODE 46867 IDENTIFIED IN THE COMPLAINT. ACCORDING TO THE DOCUMENTED RECORDS, 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. THE PRODUCT LOT NUMBER REPORTED, HAS EXPIRED. 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.

Description of Event or Problem

IT WAS REPORTED THE HEADBANDS BREAK. THIS INCIDENT WAS REPORTED TO HAVE OCCURRED DURING USE. 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.