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
Manufacturer
Grand Healthcare Co. LtdModel number
14029Catalog 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.