Puritan Bennett 180-03Recalls & reported problems
Covidien LP · Cuff Pressure Manager · Class 2
All models of Puritan Bennett (119)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521782495), received between Jul 10, 2024 and Oct 14, 2024 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (18 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Aug 22, 2023Class IIOpen, Classified
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
Z-2651-2023 · Root cause: Component design/selection · Recall details · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection18
- Charging Problem3
- Battery Problem1
- Component Missing1
- No Audible Alarm1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Unintended Extubation1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 14, 2024Smoking; Battery Problem; Smoking; Battery Problem
ACCORDING TO THE REPORTER, DURING INSTALLATION, AFTER INSERTING THE BATTERY CORRECTLY, THE UNIT BLEW AIR BRIEFLY AFTER 20 SECONDS AND STARTED SMOKING WITHOUT PUTTING THE UNIT ON. THE UNIT WAS NOT CONNECTED TO THE MAINS. THE BATTERY ALSO APPEARED TO HAVE EXPLODED. THE BATTERY WAS QUICKLY REMOVED AND THE DEVICE STOPPED SMOKING. THERE WERE NO INDICATORS OF AN ERROR. THERE WAS NO PATIENT INVOLVEMENT AND NO INJURY TO OPERATORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20446329 ↗MalfunctionOct 4, 2024Charging Problem; Charging Problem
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S POWER CORD COULD NOT CHARGE THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20375714 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE FIRST DEVICE'S CHARGING PORT CAME LOOSE INSIDE THE MONITOR AND THE SECOND DEVICE'S CHARGING PORT WAS LOOSE AND UNABLE TO CHARGE DUE TO UNFITTING CHARGER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353372 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE AUTOMATIC CUFF CONTROLLER'S CHARGING PORTS DISLODGED AND WERE INSIDE THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353322 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S POWER CONNECTION AT THE MONITOR BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353212 ↗MalfunctionOct 2, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE AUTOMATIC CUFF CONTROLLER'S CHARGING PORTS DISLODGED AND WERE INSIDE THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353133 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Charging Problem; Loose or Intermittent Connection; Charging Problem
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S BATTERY WILL CHARGE INTERMITTENTLY WITH POWER ON AS THE MONITOR CHARGING PORT WAS LOOSE BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340499 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CHARGING PORT OF THE CUFF CONTROLLER WAS DISLODGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340496 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CHARGING PORT OF THE CUFF CONTROLLER WAS DISLODGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340491 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S CHARGING PORT DISLODGED FROM THE UNIT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340488 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S CHARGING PORT DISLODGED FROM THE UNIT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340484 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE AC (ALTERNATING CURRENT) POWER CONNECTOR OF THE CUFF PRESSURE MANOMETER BROKE AND FELL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340422 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S CHARGING PORT DISLODGED FROM THE UNIT BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340279 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE METAL PRONG OF THE CUFF PRESSURE CONTROLLER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340210 ↗MalfunctionSep 30, 2024Charging Problem; Charging Problem
ACCORDING TO THE REPORTER, THE CABLE OF THE CUFF CONTROLLER WAS NOT HOLDING A CHARGE WHILE POWERED ON PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20340139 ↗MalfunctionSep 30, 2024Component Missing; Component Missing
ACCORDING TO THE REPORTER, THE CHARGING PORT OF THE CUFF CONTROLLER WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339937 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE POWER PLUG CONNECTOR OF THE CUFF CONTROLLER WAS BROKEN, UNABLE TO INSERT THE POWER CORD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339878 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE METAL PRONG OF THE CUFF CONTROLLER BROKE AND WAS LEFT IN THE OUTLET WHEN UNPLUGGED AFTER USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339683 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE FIRST DEVICE'S CHARGING PORT CAME LOOSE INSIDE THE MONITOR AND THE SECOND DEVICE'S CHARGING PORT WAS LOOSE AND UNABLE TO CHARGE DUE TO UNFITTING CHARGER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339586 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S CHARGER WAS BROKEN BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20339141 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE AUTOMATIC CUFF CONTROLLER'S CHARGING PORTS DISLODGED AND WERE INSIDE THE MONITOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20338825 ↗MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
ACCORDING TO THE REPORTER, THE CUFF CONTROLLER'S POWER CONNECTION AT THE MONITOR BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20338020 ↗MalfunctionJul 10, 2024No Audible Alarm; No Audible Alarm
ACCORDING TO THE REPORTER, THE TRACH TUBE WAS ACCIDENTALLY REMOVED FROM THE PATIENT DURING USE. IT WAS STATED THAT THE CUFF WAS SLIGHTLY INFLATED. WHEN THE TUBE WAS REMOVED, AN AIR WAS INJECTED IN THE CUFF AND SPONTANEOUSLY CAME OUT. IT WAS DIPPED INTO THE WATER AND A PINHOLE WAS DETECTED. THE CUFF PRESSURE WAS ALSO REPORTED NOT ALARMED OR DID NOT SOUND WHEN THE ISSUE HAPPENED. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 19711614 ↗
Other Cuff, tracheal tube, inflatable devices
- IntelliCuff 951001Hamilton Medical AG · Cuff, Tracheal Tube, Inflatable1 recall202 reports
- Medex 292004Icu Medical, Inc. · Cuff, tracheal tube, inflatable3 reports
- NA 2010770Nuvasive, Inc. · Cuff, tracheal tube, inflatable1 report
- MEDLINE HCSCUFF0041Medline Industries, Inc. · Cuff, tracheal tube, inflatable1 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 · each recall links to the FDA recall notice
- 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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