inforMED
MalfunctionBTI

Medline

Received Jul 31, 2026 · Event occurred Jul 8, 2026

Report 1417592-2026-08095 · MDR key 50104914

Device

Generic name

Compressor,nebulizer,aeromist Compact

Catalog number

HCS70004

Lot number

6462112

Product problems

  • Infusion or Flow Problem

Patient

Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that the device is not misting.

Additional Manufacturer Narrative

It was reported that the "medicine is not coming out of the machine, and the noise is quieter." Customer also reported that the tubing and the mask are ruined. There were no reports of death, serious injury, medical intervention, or follow up care. It has been determined that the reported event could cause or contribute to serious injury if it were to occur again. In an abundance of caution, this is a reportable event. If additional information becomes available this report will be reopened and reevaluated.