MAYFIELD PEDIATRIC HORSESHOE HEADREST

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THE FOLLOWING: 1. PLEASE VERIFY THE DATE OF EACH INCIDENT. (B)(6)2024. 2. WAS MEDICAL/SURGICAL INTERVENTION REQUIRED? IF YES, WHAT REVISION/INTERVENTION WAS PERFORMED DURING EACH INCIDENT? MEDICAL INTERVENTION POST PROCEDURE INCLUDED INPATIENT AND OUTPATIENT WOUND THERAPY TREATMENTS. 3. WAS THERE A DELAY IN SURGERY DUE TO PRODUCT PROBLEM? IF YES, HOW LONG (IN MINUTES)? NO DELAY IN SURGERY, 4. HOW WAS THE PROCEDURE COMPLETED FOR EACH INCIDENT? PATIENT WAS POSITIONED PRONE FOR SURGERY, INCIDENT NOTICED AFTER PROCEDURE COMPLETED. 5. PLEASE PROVIDE PATIENT OUTCOME FOR EACH INCIDENT. PATIENT HAD BILATERAL PRESSURE INJURIES TO CHEEK AREAS NOTED AFTER PROCEDURE FINISHED. THE PATIENT HAD TO RECEIVE INPATIENT AND EXTENSIVE OUTPATIENT WOUND THERAPY TREATMENT. 6. PLEASE PROVIDE PATIENT INFORMATION: A. DATE OF BIRTH: (B)(6) 2024. B. AGE: 3 MONTHS AT TIME OF SURGERY. C. GENDER: MALE. D. WEIGHT: 6.6KG. E. ETHNICITY (HISPANIC/LATINO, NOT HISPANIC/LATINO): HISPANIC OR LATINO.

Description of Event or Problem

THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3004608878-2024-00106, 3004608878-2024-00108, 3004608878-2024-00109. 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

THE MAYFIELD PEDIATRIC HORSESHOE HEADREST (B)(6) WAS NOT RETURNED FOR EVALUATION BECAUSE THE HOSPITAL DISCARDED THE OLD MAYFIELD HEADREST (B)(6) WHEN THE NEW HEADREST WAS DELIVERED. ADDITIONALLY, THE SERIAL NUMBER HAS NOT BEEN PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE DEFINITE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. 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.