PREVALON AIRTAP QC SYS 5

Description of Event or Problem

REPORT RECEIVED OF SERIOUS BILATERAL ISCHIAL PRESSURE INJURIES RELATED TO THE USE OF AIRTAP WEDGES. REPORTEDLY, A (B)(6)-YEAR-OLD MALE PATIENT WAS ADMITTED FROM A NURSING HOME TO THE TELEMETRY UNIT OF THE FACILITY ON (B)(6) 2025 FOR ACUTE RESPIRATORY FAILURE WITH HYPOXIA. THE PATIENT WAS NON-VERBAL, NOT ALERT OR ORIENTED, AND IMMOBILE. PER THE REPORTER THE PATIENT WAS ADMITTED AT 141 LBS. AND WAS 65 INCHES. THE PATIENT APPEARED EMACIATED, PER THE REPORTER, ALTHOUGH HE REPORTEDLY ONLY LOST 5 POUNDS DURING HIS ADMISSION. THE PATIENT HAD A HEALING STAGE 3 SACRAL PRESSURE ULCER ON ARRIVAL, AND A BRADEN SCORE OF 11. PER HOSPITAL PROTOCOL, THE PATIENT WAS PLACED ON AN AIRTAP DEVICE (GLIDE SHEET AND WEDGES) ON ADMISSION, AND 5 DAYS AFTER ADMISSION ON (B)(6) 2025, WAS PLACED ON A LOW AIR FLOW MATTRESS. PER THE REPORTER, HOSPITAL PROTOCOL IS TO TURN THE PATIENT EVERY TWO HOURS, HOWEVER, THE REPORTER DID NOT CONFIRM THAT THIS WAS DOCUMENTED IN THE RECORD. ON (B)(6) 2025 THE WOUND OSTOMY CARE NURSE (WOCN) ASSESSED A RIGHT ISCHIUM SMEAR OF DISCOLORATION. THIS WAS INITIALLY ASSESSED AS A FRICTION SKIN INJURY. ON (B)(6) 2025 THE WOCN ASSESSED BILATERAL ISCHIAL NON-BLANCHABLE AREAS OF DISCOLORATION. SHE ASSESSED THIS AS BILATERAL ISCHIAL DEEP TISSUE PRESSURE INJURIES (DTPI). ON (B)(6) 2025 THE WOCN ASSESSED THE PATIENT ON THIS DAY AND NOTED THAT THE EPIDERMIS OF THE WOUND AREAS WAS PEELING OFF, AND THE WOUNDS GREW TO 6X4IN ON LEFT ISCHIUM AND 4X4IN. ON THE RIGHT ISCHIUM. THE WOUNDS WERE TREATED WITH MEDICATION (SANTYL). THE PATIENT WAS SCHEDULED TO BE DISCHARGED ON THIS DAY; HOWEVER, FAMILY MEMBERS EXPRESSED CONCERN ABOUT THE NURSING HOME'S ABILITY TO PROVIDE CARE THAT WOULD HELP THE WOUNDS HEAL. THEREFORE, THE PATIENT¿S DISCHARGE WAS CANCELLED. THE REPORTER STATED THAT THE WEDGES WERE PLACED PER THE INSTRUCTIONS FOR USE, AND DID NOT HAVE ANY VISIBLE DEFECTS OR QUALITY ISSUES. AS THE PATIENT'S HEAD OF BED WAS RAISED, THE PATIENT ENDED UP SITTING ON THE LOWER WEDGE THAT WAS PLACED UNDER THE POSTERIOR THIGH. ON (B)(6) 2025, A PLASTIC SURGEON AT THE FACILITY ASSESSED THE PATIENT AND DETERMINED THAT THE WEDGES WERE A CONTRIBUTING FACTOR IN THE DEVELOPMENT OF THE PATIENT¿S BILATERAL ISCHIAL WOUNDS. THE WEDGES WERE DISCONTINUED ON THIS DAY, HOWEVER, THE PATIENT REMAINED ON THE GLIDESHEET WITH PILLOWS BEING USED TO REPOSITION HIM FROM SIDE TO SIDE. ON (B)(6) 2025 THE PATIENT UNDERWENT SURGICAL DEBRIDEMENT, AS THE WOUNDS WERE NOT HEALING IN RESPONSE TO TREATMENT WITH SANTYL. AFTER SURGICAL DEBRIDEMENT THE WOUNDS LOOKED "BIGGER" AND HAD SOME REMAINING SLOUGH. THE WOUNDS WERE FULL THICKNESS WITH SOME NON-VIABLE TISSUE. THE TREATMENT AFTER THE SURGICAL DEBRIDEMENT WAS SANTYL, WET TO DRY DRESSING AND FOAM DRESSINGS. THE PATIENT UNDERWENT SUBSEQUENT BEDSIDE DEBRIDEMENTS, ONE OCCURRING EVERY 7-10 DAYS. ON (B)(6) 2025, THE WOCN ASSESSED THE RIGHT ISCHIAL WOUND AS A FULL THICKNESS WOUND WITH BLEEDING WHICH THE WOCN INDICATED IS A SIGN OF HEALING. THE WOCN ASSESSED THE LEFT ISCHIAL WOUND WAS EXTENDING DOWN TO THE BONE. ON (B)(6) 2025, THE PATIENT UNDERWENT ANOTHER BILATERAL WOUND DEBRIDEMENT. THE BILATERAL ISCHIAL PRESSURE WOUNDS ARE NOW BOTH EXTENDING DOWN TO THE BONE. HOWEVER, BOTH HAD BLEEDING AFTER THE DEBRIDEMENT, WHICH THE WOCN INDICATED IS A SIGN OF HEALING. THE PATIENT IS VERY STIFF BUT NOT CONTRACTED. HE IS CURRENTLY ON HIGH FLOW NASAL CANNULAR WITH FI02 AT 30%, AND HIS O2 SATURATION IS 98% WITH THIS THERAPY. HIS MOST RECENT ALBUMIN LEVEL IS 1.6 AS OF (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED, THE WEDGES IN USE WERE DISCARDED, AND NO LOT INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

THE COMPLAINANT DID NOT PROVIDE PHOTOGRAPHS OF THE AFFECTED DEVICE, DID NOT RETURN THE AFFECTED DEVICE AND DID NOT PROVIDE THE LOT NUMBER OF THE AFFECTED DEVICE FOR THE INVESTIGATION. THEREFORE, NEITHER A VISUAL/FUNCTIONAL INSPECTION, NOR A PRODUCT HISTORY REVIEW FOR THE AFFECTED DEVICE COULD BE PERFORMED. HOWEVER, PRIOR TO THE RELEASE OF THE FINISHED GOOD COMPONENTS UNDERGO INSPECTION PERFORMED BY INCOMING QUALITY ASSURANCE TO ENSURE THAT THE COMPONENTS ARE MANUFACTURED TO SPECIFICATION. A LABELING REVIEW WAS PERFORMED. THE FOLLOWING IS STATED WITHIN THE PRODUCT INSTRUCTIONS FOR USE: ANCHOR WEDGE, TAIL FIRST AND WITH THE BLACK FABRIC FACING UP, SO THAT THE ANCHOR IS UNDERNEATH THE PATIENT¿S THIGHS. INSERT THE UPPER WEDGE AT LEAST ONE HAND WIDTH AWAY FROM THE ANCHOR WEDGE. AFTER THE GLIDE SHEET IS FULLY DEFLATED, CHECK TO ENSURE THE PATIENT¿S SACRUM IS OFFLOADED. NO MISUSE OR DEVIATION FROM THE IFU WAS REPORTED BY THE COMPLAINANT. A RISK ASSESSMENT WAS CONDUCTED, WHICH CONCLUDED THERE IS NO CURRENT RISK IDENTIFIED IN THE RISK FILE THAT CORRECTLY ALIGNS WITH THE REPORTED ISSUE. THEREFORE, A NONCONFORMANCE WAS OPENED TO ADDRESS THIS NEW HAZARD.

Description of Event or Problem

AN UPDATE ON THE PATIENT STATUS WAS RECEIVED BY THE REPORTER ON (B)(6) 2025. PER THE REPORTER, THE PATIENT IS STILL INPATIENT AT THE FACILITY. THE WOUND IS STILL ASSESSED AS A BILATERAL ISCHIAL DEEP TISSUE INJURY WITH BILATERAL BONE EXPOSURE. THE LAST DEBRIDEMENT OF THE WOUND TOOK PLACE 2-3 WEEKS AGO. THE CARE TEAM FEELS THE WOUND HAS BEEN SUFFICIENTLY DEBRIDED; THEREFORE, NO FURTHER DEBRIDEMENTS ARE PLANNED. A WOUND VAC WAS PLACED LAST WEEK TO ASSIST IN WOUND HEALING. THE REPORTER STATED THE WOUND IS NOT INFECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.