AffloVest 8200Recalls & reported problems
Movair, Inc. · The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814321020056), received between Dec 19, 2018 and Dec 19, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2018Insufficient Device Problem Information
RESPIRATORY THERAPIST WAS INFORMED THAT THE USER SUFFERED SEVERAL BROKEN RIBS.
Patient problems: Bone Fracture(s)
MAUDE report 8178717 ↗
Other Percussor, Powered-Electric devices
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- The Vest APX System M08368Hill-Rom Services Pte. Ltd. · PERCUSSOR, POWERED-ELECTRIC1 death14 reports
- Smartvest Clearway Air Pulse GeneratorElectromed, Inc. · Percussor, Powered-Electric6 reports
- The Vest®System P105cmHill-Rom Services Pte. Ltd. · PERCUSSOR, POWERED-ELECTRIC4 reports
- The Vest®System P105BTHill-Rom Services Pte. Ltd. · PERCUSSOR, POWERED-ELECTRIC4 reports
- The Vest APX System M08463Hill-Rom Services Pte. Ltd. · PERCUSSOR, POWERED-ELECTRIC3 reports
- The Vest®System P205cmHill-Rom Services Pte. Ltd. · PERCUSSOR, POWERED-ELECTRIC1 death2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.