inforMED
InjuryFNM

Drive Medical MedAire8 LowAirLoss.w/Pump system

Received Jul 29, 2026 · Event occurred Jul 1, 2026

Report 2438477-2026-00050 · MDR key 50072299

Device

Generic name

Mattress, Air Flotation, Alternating Pressure

Model number

14029

Catalog number

14029

Product problems

  • Mechanical Problem

Patient

Not reported

  • Pressure Sore/Ulcer

Narrative

Description of Event or Problem

Drive Medical was notified by the device provider of an incident involving a pressure prevention mattress, which is intended to be used as one component of a comprehensive, multi-disciplinary pressure injury management program. The device provider reported that the mattress does not remain inflated when the head section is elevated. According to the report, the loss of inflation resulted in the end user coming into contact with a bar beneath the mattress surface, which allegedly contributed to the development of pressure sores on the end user's buttocks. As part of its complaint review and evaluation process, Drive Medical will also notify the manufacturer of the product about this complaint.