PROCHAMBER Assembly 00Recalls & reported problems
Respironics Respiratory Drug Delivery (Uk) Ltd · PROCHAMBER RETAIL - 10PK · Class 2
Data updated Oct 16, 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 00383730000671), received between Jul 12, 2022 and Jul 12, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 16, 2026.
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- Bronchospasm1
- Cough1
- Low Oxygen Saturation1
- Respiratory Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
THE MANUFACTURER WAS MADE AWARE OF AN ALLEGATION BY AN END USER THAT A PROCHAMBER VALVED HOLDING CHAMBER DEVICE WAS DEFECTIVE, CAUSING MEDICATION TO LEAK FROM HER INHALER, THEREBY REDUCING THE DOSAGE. THE USER STATED HER OXYGEN SATURATION LEVEL WAS BELOW 90%, AND SHE EXPERIENCED COUGHING, TIGHTNESS AND PAIN IN THE CHEST, AND REQUIRED PRESCRIPTION ANTIBIOTICS. THE USER WAS PRESCRIBED 2 DIFFERENT INHALERS (WIXELA INHUB AND OTHER UNKNOWN). THE USER DID NOT STATE CLEARLY WHICH INHALER DID NOT FIT IN THE PROCHAMBER, HOWEVER THE WIXELA INHALER WOULD NOT BE COMPATIBLE WITH THE PROCHAMBER DUE TO ITS DESIGN AND INTENDED USE AS A MAINTENANCE INHALER. THE USER RETURNED THE PROCHAMBER TO THE STORE SHE PURCHASED IT FROM AND IT IS NOT AVAILABLE FOR INVESTIGATION. THE PROCHAMBER IS A VALVED HOLDING CHAMBER FOR THE ACUTE RESPIRATORY CARE SETTING. IT IS NOT REQUIRED TO USE THIS CHAMBER WHEN USING AN INHALER, BUT CAN HELP TO BETTER DELIVER THE INHALED MEDICINE TO THE LUNGS. BASED ON THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES NO FURTHER ACTION IS NECESSARY.
Patient problems: Bronchospasm; Cough; Low Oxygen Saturation; Respiratory Tract Infection
MAUDE report 14987154 ↗
Other SPIROMETER, THERAPEUTIC (INCENTIVE) devices
- Portex 21-1530Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 recall1 report
- HUDSON RCI IPN049141Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- HUDSON RCI IPN049316Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)3 reports
- Portex 22-4000Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)2 reports
- Portex 27-9000Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)2 reports
- HUDSON RCI IPN049142Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 22-2500Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
- Portex 27-9001Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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