# Codebook: FDA reports on pressure-relief mattresses and overlays (product codes FNM and IKY) Written before any report in the set was coded. Mobility Atlas study, October 2026. ## Pool Every FDA MAUDE device report filed under product code FNM ("Mattress, Air Flotation, Alternating Pressure", 21 CFR 880.5550) or IKY ("Mattress, Flotation Therapy, Non-Powered", 21 CFR 890.5170) and received 1 January 2019 to the last openFDA update read on 16 October 2026 (data last updated 7 October 2026) that carries text: 1,825 reports, all coded. ## What you record for each report One line per report: `report_key,surface,category,injury,fall,setting,inspection,finding,note` ### SURFACE (one letter), from the report text; the brand or generic name may be used when the text does not say - A: a POWERED air surface: alternating pressure, low air loss, lateral rotation, or any mattress or overlay with a pump or blower. - F: a NON-POWERED surface: foam, gel, static air or water mattress, overlay or pad with no pump. - S: a STRETCHER, gurney, procedure-table or operating-table pad or mattress. - U: the report does not say, or you cannot tell. ### CATEGORY (one letter): what the report says went wrong. Precedence: the FIRST letter that applies wins. 1. E: ENTRAPMENT: a person's head, neck, chest or limb was caught or wedged between the mattress and a rail, the bed frame, the headboard or footboard, or another gap. 2. H: FIRE, HEAT OR ELECTRICAL: smoke, sparks, flames, melting, burning smell, overheating, an electric shock, a damaged power cord, from the pump, blower, cord or mattress. 3. R: CPR OR RAPID DEFLATION FAILED: the CPR release, CPR valve or emergency deflation did not work or was too slow, or the surface deflated by itself through the CPR control. 4. D: DEFLATION: the mattress lost air, would not inflate, went flat, bottomed out, or the person ended up on the bed frame, including after a power loss, a disconnected hose, a leak or a puncture. 5. O: OVERINFLATION OR FIRMNESS: too firm, overinflated, inflated unevenly, bolsters or sides too high or too low, cells bulging. 6. P: PUMP, CONTROL OR ALARM: the pump, blower, control unit, display, hose or alarm failed, made noise or gave errors, with no deflation, overinflation or heat described. 7. C: COVER OR FLUID INGRESS: a cover, seam or zipper tore, cracked, wore through, or fluid, blood or contamination got inside the mattress or cover; includes stained or soiled inner foam found on inspection. 8. F: FALL OR SLIDE with no failure from 1-7 named: the person slid or rolled off the mattress, the mattress slid on the frame, the edge was too soft. 9. K: SKIN: a pressure injury, burn, rash or skin damage attributed to the surface, with no failure from 1-8 named. 10. M: HANDLING: someone was hurt lifting, moving or cleaning the mattress, or it was too heavy. 11. X: no device problem stated, or only labeling, delivery, cleaning instructions or ordering issues. 12. U: a device problem is alleged but you cannot tell which kind. - N: no event involving a mattress or overlay is described. ### FLAGS (y or n) - injury: the report states harm to the body or medical care (bruise, fracture, pressure injury, infection, burn, hospital, death). y when the event type is Death. - fall: the person fell or slid off the mattress or bed to the floor. - inspection: the report describes findings from an inspection, audit or survey of surfaces (for example under a safety alert) rather than a single event with a patient. ### SETTING (one letter) - H: a private home, a family member or a home carer is named. - C: a hospital, nursing home, assisted living, hospice facility, or their staff. - U: cannot tell. ### FINDING (one letter): what the maker found, as the report states it - D: a fault was found or confirmed, or a part was replaced because it was faulty. - N: no fault found, worked as designed, or the cause was outside the device (misuse, wrong settings, wrong bed frame, damage by users, cleaning chemicals, age beyond service life). - X: not evaluated, not returned, or nothing stated. ### note At most 15 words: the part, what made the choice hard. No quotes longer than 6 words. No personal details. ## Output format CSV with header `report_key,surface,category,injury,fall,setting,inspection,finding,note`, one row per report in your chunk, nothing else. Every report gets exactly one row.