INVASIVE CIRCUIT 00Recalls & reported problems
Respironics, Inc. · INV DISP CIRCUIT, SINGLE, CHINA · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959008854), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- Dyspnea1
- Hypoxia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2024Material Puncture/Hole; Material Puncture/Hole
THE MANUFACTURER RECEIVED INFORMATION ALLEGING ON "(B)(6) 2024, THE CLINICAL DEPARTMENT RECEIVED TYPE II RESPIRATORY FAILURE PATIENTS, MONITORING THE BLOOD OXYGEN SATURATION OF 85% AT ADMISSION, AND THE CLINICIAN USED THE VENTILATOR TO PROVIDE RESPIRATORY SUPPORT TO THE PATIENT, MONITORING THE BLOOD OXYGEN SATURATION OF 98%: ONE HOUR LATER, THE VENTILATOR ALARM AND THE MONITOR ALARM LOW BLOOD OXYGEN SATURATION, THE PATIENT'S BLOOD OXYGEN SATURATION DECREASED TO 87% AND GRADUALLY DECREASED, THE PATIENT'S SHORTNESS OF BREATH SIGNIFICANTLY INCREASED, AND THE RESPIRATORY PIPE PRESSURE DETECTOR WAS FOUND TO BE BROKEN AND LEAKING, RESULTING IN THE PATIENT'S BLOOD OXYGEN SATURATION DECREASED TO 87% AND GRADUALLY DECREASED, AND A NEW BREATHING PIPE PRESSURE DETECTOR WAS IMMEDIATELY REPLACED TO ADJUST THE OXYGEN PRESSURE OF THE VENTILATOR. AFTER TREATMENT, THE PATIENT'S BLOOD OXYGEN SATURATION INCREASED TO 98%, AND HER VITAL SIGNS RETURNED TO STABILITY".
Patient problems: Dyspnea; Hypoxia
MAUDE report 18924491 ↗
Other VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE devices
- Philips Respironics V60Respironics California, Inc. · Ventilator, Continuous, Minimal Ventilatory Support,Facility Use3 recalls30 deaths13,525 reports
- PHILIPS 1076716Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death2,946 reports
- PHILIPS 1076709Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use8 deaths2,174 reports
- PHILIPS 1053614Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls4 deaths1,203 reports
- BiPAP A40 EEX3100S19Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls422 reports
- BiPAP A40 DEX3100S13Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls164 reports
- BiPAP A40 ITX3100S21Respironics, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls163 reports
- PHILIPS 1053613Respironics California, Inc. · Ventilator, continuous, minimal ventilatory support, facility use2 recalls1 death161 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.