PRODUCT CODE BZD
Ventilator, Non-Continuous (Respirator)
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Reporting increase · investigate. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
23,685Prior 90 days: 12,860Injury reports
31Source-classified event typeDeath reports
1Reported relationship is unverifiedReporting change
84.2%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 23,644. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
REMstar
Read FDA report 50520061 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Degraded
REMstar Auto A-Flex
Read FDA report 50523575 ↗Received 2026-08-31 · Injury
Patient problems: Cancer
Device problems: Degraded
BiPAP Auto BiFlex
Read FDA report 50524413 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Degraded
DreamStation
Read FDA report 50528585 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Degraded
DS2Adv Auto CPAP
Read FDA report 50531401 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Thermal Decomposition of Device
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.