The MetaNeb®System 181863Recalls & reported problems
Hill-Rom Services Pte. Ltd. · Respiratory Care · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761997387), received between Dec 6, 2018 and Mar 25, 2020 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pneumothorax2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem
HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE METANEB SYSTEM POTENTIALLY CONTRIBUTED TO THE PATIENT¿S PNEUMOTHORAX DUE TO NO PREVENTATIVE MAINTENANCE SINCE 2017 ON ALL THREE DEVICES THAT THE HOSPITAL OWNS. THE PATIENT WAS ADMITTED ON (B)(6) 2020 WITH SHORTNESS OF BREATH THAT PROGRESSED TO PNEUMONIA. ON (B)(6) 2020, THE PATIENT HAD A CONFIRMED PNEUMOTHORAX, AFTER A CHEST X-RAY WAS COMPLETED AND WAS MOVED TO THE INTENSIVE CARE UNIT. FURTHER INFORMATION WAS REQUESTED BY THE ACCOUNT WITH UNSUCCESSFUL ATTEMPTS. A PNEUMOTHORAX IS ALSO CALLED A COLLAPSED LUNG AND IS CONSIDERED A SERIOUS INJURY. A PNEUMOTHORAX CAN BE CAUSED BY A BLUNT OR PENETRATING CHEST INJURY, CERTAIN MEDICAL PROCEDURES, OR DAMAGE FROM UNDERLYING LUNG DISEASE. THE MAIN SYMPTOMS OF A PNEUMOTHORAX ARE SUDDEN CHEST PAIN AND SHORTNESS OF BREATH. THE DEVICES WERE LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: Pneumothorax
MAUDE report 9878238 ↗InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT DEVELOPED A SMALL TO MODERATE RIGHT PNEUMOTHORAX AND SMALL LEFT BASILAR PNEUMOTHORAX. THE DEVICE WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: Pneumothorax
MAUDE report 8137534 ↗
Other DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT devices
- Percussionaire P5Percussionaire Corporation · Device, Positive Pressure Breathing, Intermittent4 recalls2 reports
- Volara System M08473Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT3 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls3 reports
- Volara System M08085Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Percussionaire F00001-C-FRPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
- Volara System M07937Hill-Rom Services Pte. Ltd. · DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT2 recalls0 reports
- Percussionaire F00001-CPercussionaire Corporation · Device, Positive Pressure Breathing, Intermittent2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.