Bipap A40 Pro
Received Jul 31, 2026 · Event occurred Jul 25, 2026
Report 2518422-2026-040801 · MDR key 50100640
Device
Generic name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Manufacturer
Respironics, Inc.Model number
DEX3100S13Catalog number
DEX3100S13
Product problems
- Circuit Failure
- Electrical /Electronic Property Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A BiPAP A40 Prodevice was returned to a third-party service center in reference to the voluntary Field Safety Notice/recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There is no allegation of serious or permanent harm or injury. The device was not documented to be in patient use.During the evaluation of the device, the service technician identified a ventilator inoperative error code E-50 indicating "The difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds." According to the service technician, error code E-50 was identified as the cause of the faulty PCA. No repair was performed. The device was scrapped by the service center after the evaluation was completed.
Additional Manufacturer Narrative
DHR review was performed for the complaint device SN. Review confirms that the device met the final acceptance criteria and was released for final distribution.During the evaluation of the device, the service technician identified a ventilator inoperative error code E-50 indicating "The difference between the blower pressure sensor reading and the outlet pressure sensor reading is 10 cmH2O or greater for 5 seconds." According to the service technician, error code E-50 was identified as the cause of the faulty PCA. No repair was performed. The device was scrapped by the service center after the evaluation was completed.
Remedial action
- Recall