MAYFIELD PEDIATRIC HORSESHOE HEADREST

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THE FOLLOWING: PLEASE VERIFY THE DATE OF EACH INCIDENT. 8/6/2024. WAS MEDICAL/SURGICAL INTERVENTION REQUIRED? IF YES, WHAT REVISION/INTERVENTION WAS PERFORMED DURING EACH INCIDENT? NO. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG (IN MINUTES)? NO DELAY IN SURGERY. HOW WAS THE PROCEDURE COMPLETED FOR EACH INCIDENT? PATIENT WAS SUPINE WITH FACE TURNED TO LEFT SIDE, PRESSURE INJURY NOTED TO LEFT SIDE OF CHEEK AFTER PROCEDURE COMPLETED. PLEASE PROVIDE PATIENT OUTCOME FOR EACH INCIDENT. OBSERVATION WITHOUT INTERVENTION. PLEASE PROVIDE PATIENT INFORMATION: DATE OF BIRTH: (B)(6) 2009. AGE: 14 YEARS OLD. GENDER: FEMALE. WEIGHT: 55KG. ETHNICITY (HISPANIC/LATINO, NOT HISPANIC/LATINO): NOT HISPANIC OR LATINO. RACE (ASIAN, AMERICAN INDIAN OR ALASKAN NATIVE, BLACK OR AFRICAN AMERICAN, WHITE, NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER): WHITE.

Description of Event or Problem

THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00106 3004608878-2024-00107 3004608878-2024-00108. A FACILITY REPORTED THAT FOUR INCIDENCES OF PRESSURE INJURY OCCURRED AFTER USING THE MAYFIELD SWIVEL HORSESHOE HEADREST (A1012) AND THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051). IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY; HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONALLY, THE FACILITY HAS INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE AND IS PERFORMING A MULTIFACTORIAL ROOT CAUSE ANALYSIS.

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (A1051) WAS NOT RETURNED FOR EVALUATION BECAUSE THE HOSPITAL DISCARDED THE OLD MAYFIELD HEADREST A1051 WHEN THE NEW HEADREST WAS DELIVERED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE DEFINITE ROOT CAUSE CANNOT BE DETERMINED DUE TO PRODUCT UNAVAILABILITY. HOWEVER, BASED ON THE REPORTED COMPLAINT, PROBABLE ROOT CAUSE IS IMPROPER OR SUBOPTIMAL USE AND POSITIONING OF THE DEVICE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

Description of Event or Problem

N/A.