OPTICHAMBER DIAMOND 00 (REF 1098214)Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · OPTICHAMBER DIAMOND W SM MASK- CANADA · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00383730000336), received between Nov 23, 2017 and Nov 23, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Respiratory Distress1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 23, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
PATIENT CAREGIVER REPORTED THAT THE (B)(6) PATIENT WAS ADMITTED TO HOSPITAL OVERNIGHT DUE TO USE OF AN OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER DEVICE WITH A SMALL LITETOUCH MASK THAT WAS TOO SMALL FOR THE PATIENT, AND THEREFORE PATIENT DID NOT GET THE MEDICATION NEEDED. PATIENT WAS DISCHARGED WITH A LARGER MASK. CAREGIVER STATES HER DAUGHTER IS DOING FINE NOW.
Patient problems: Respiratory Distress
MAUDE report 7057130 ↗
Other NEBULIZER (DIRECT PATIENT INTERFACE) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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