# Codebook: FDA reports on powered wheelchairs and power add-ons (product code ITI) Written before any report in the set was coded. Mobility Atlas study, October 2026. ## Pool (how the reports were found) Every FDA MAUDE device report filed under product code ITI ("Wheelchair, Powered") and received by the FDA from 1 January 2024 to the last openFDA update read on 10 October 2026, as downloaded from api.fda.gov on 10 October 2026 (1,296 reports). Reports with no narrative text at all (29) cannot be read and are counted but not coded. Every report with any narrative is in the pool. The narrative is the "Description of Event or Problem" plus every other text section of the report (manufacturer narratives included). Note: FDA's product code ITI also covers power-assist devices that attach to a manual wheelchair (for example the SmartDrive). They are in the pool and are marked by the DEVICE field. ## What you record for each report One line per report: `report_key,device,category,injury,fall,retro,note` ### DEVICE (one letter): what kind of powered device the report is about - C: a power wheelchair (a chair driven by its own motors, steered with a joystick or other control) - A: a power add-on or power-assist device fitted to a manual wheelchair (SmartDrive, e-fix, e-motion, SMOOV, Firefly, a power-assist wheel or a front attachment) - S: a mobility scooter - O: something else, or the report does not let you tell (write what in the note) Use the narrative. The brand field may be used only when the narrative does not name the device type (SmartDrive is A; Permobil F3/F5/M3/M5 Corpus, Pride Jazzy, Quantum, Quickie power chairs are C). ### RELEVANCE - N: no event or problem involving the device is described (the text is blank, administrative only, or about a different product). Record N in the category column and leave the flags n. ### CATEGORY (one letter): what the report says went wrong. Choose by the precedence list: the FIRST letter that applies wins. 1. M: unintended or uncontrolled MOTION. The device moved, accelerated or kept running when the user did not command it, or would not stop when commanded (motor did not disengage, runaway, joystick or control stuck in drive, chair drove on its own, sudden lurch or veer). This includes a seat function that moved on its own if the chair also moved; seat-only movement is P. 2. B: BRAKES or holding. The device would not stop or hold when stopped (brakes failed, rolled away on a slope, freewheel lever left engaged and rolled, parking brake failure). 3. F: FIRE, smoke, melting, burning smell, overheating or sparks, from any part (battery, charger, wiring, motor, controller). 4. E: other ELECTRICAL or power failure: sudden loss of power or stopping, would not turn on, would not charge, battery failure, error codes, display, controller or wiring fault without fire or smoke. 5. S: STRUCTURAL or mechanical failure: a part broke, cracked, came loose, detached or wore out (frame, seat post, seat, back, armrest, footplate, leg rest, wheel, tire, caster, fork, axle, motor mount, clamp, mounting hardware, drive wheel of an add-on). 6. P: POWERED SEATING or positioning function: tilt, recline, seat elevator, standing, power leg rests or actuators moved unexpectedly, pinched or trapped a body part, or failed. 7. T: TIP-over, fall or loss of stability (tipped back, sideways or forward; fell off a curb, ramp, step or lift; user fell out) and the report does NOT name a device fault from 1-6 as the cause. 8. X: the report describes an event with the device but states NO device problem (struck by a vehicle, user or caregiver action, medical event, the manufacturer found no fault) and none of 1-7 is alleged. 9. U: a device problem is alleged but you cannot tell what it was. If the reporter alleges a fault (for example "the chair took off on its own") and the manufacturer later says it found no fault, code the ALLEGED fault (M) and say "maker found no fault" in the note. ### FLAGS (y or n) - injury: the report states that a person was injured, needed medical care, or died. "No injury reported" = n. A possible injury that the report does not say happened = n. - fall: the report states that the user fell or was thrown from the device, or the device tipped over, whatever the cause. - retro: the report says it was filed as part of a retrospective review, remediation effort or CAPA-driven re-filing of past complaints (words such as "retrospective review", "remediation effort", "previously reported per 21 CFR 803.50" together with a retrospective filing). ### note At most 15 words: the part or function named, and anything that made the choice hard. No quotes longer than 6 words. Never include personal details. ## Output format CSV with header `report_key,device,category,injury,fall,retro,note`, one row per report in your chunk, nothing else. Every report in the chunk gets exactly one row.