MASK PFR95 FS SMALL

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. THE INVESTIGATION FOUND THE POSSIBLE ROOT CAUSE WAS INCORRECT POSITION OF THE ELASTIC HEADBAND DURING MANUFACTURE, WHICH MAY IMPACT THE QUALITY OF SEALING. ACCORDING TO ANNUAL CALENDAR FOR EQUIPMENT MAINTENANCE, THE CHECKLIST OF PM (PREVENTIVE MAINTENANCE) INDICATES THAT EVERY 9 WEEKS A GENERAL MAINTENANCE IS PERFORMED ON THE MACHINE. THE DHR (DEVICE HISTORY RECORD) REVIEW FOUND THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. 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 CUSTOMER REPORTED THE STRAPS BROKE DURING USE. ADDITIONAL DETAILS OF INCIDENT HAVE BEEN REQUESTED, HOWEVER, NOT PROVIDED BY THE REPORTER. 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.