DAR 352/5877 (UDI 20884522039649)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20884522039649), received between Jun 14, 2023 and Feb 10, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (10 reports).

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

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT AN AIR LEAK OCCURRED INVOLVING A CIRCUIT, BREATHING AND FILTER, AND THE LOCATION WAS UNKNOWN PRIOR TO USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309151 ↗
• MalfunctionNov 17, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-USE INSPECTION, THE LEAK TEST OF THE ANESTHESIA MACHINE DID NOT PASS FROM THE BREATHING SYSTEM CIRCUIT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569886 ↗
• MalfunctionSep 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO USE, ALL THREE DEVICES HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066511 ↗
• MalfunctionApr 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING PRE-USE TESTING, A LEAK ALARM SOUNDED AND THE PRODUCT COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858457 ↗
• MalfunctionDec 11, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER THE ARTIFICIAL NOSE WAS CONNECTED TO THE PATIENT, THE AIR PRESSURE COULD NOT BE INCREASED. INSPECTION EVENTUALLY REVEALED THAT THE ARTIFICIAL NOSE LEAKED AIR. AFTER IT WAS REPLACED WITH A NEW ARTIFICIAL NOSE OF THE SAME MODEL, IT OPERATED NORMALLY. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901416 ↗
• MalfunctionNov 1, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A LEAK WHEN PRE-CHECKED. SEVERAL CRACKS APPEARED AROUND THE CAP WHEN THE EXTERIOR WAS CHECKED TO SEE WHERE THE LEAK WAS COMING FROM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586650 ↗
• MalfunctionOct 21, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, A LEAK ALARM SOUNDED FROM THE ANESTHESIA MACHINE. THE FILTER WAS REPLACED AND THE ALARM STOPPED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496047 ↗
• MalfunctionSep 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE FILTER WAS SPLIT IN HALF AND WAS DETACHED FROM THE VENTILATOR, AS SHOWN IN THE ATTACHED IMAGE. THE FILTER WAS REPLACED IMMEDIATELY WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273993 ↗
• MalfunctionSep 10, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USAGE, THERE WAS A CRACK FOUND IN THE BREATHING SYSTEM FILTER WHICH CAUSED AN AIR LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180129 ↗
• InjurySep 6, 2024Filtration Problem; Filtration Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN INABILITY TO ANALYZE THE CAPNOGRAPHY MONITORING WHICH WAS ASSOCIATED WITH THE RUPTURE OF THE FILTER USED TO OCCLUDE THE CAPNOGRAPHY LINE AND LED TO THE DESATURATION OF THE PATIENT, THE ABSENCE OF CAPNOGRAPHY AND PREVENTED THE DIFFERENTIAL DIAGNOSIS OF THE ETIOLOGY OF THE EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20163297 ↗
• InjuryAug 22, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PATIENT BECAME UNWELL IMMEDIATELY AFTER THE EXCHANGE OF FILTER AND RINGED FITTING. A LEAK WAS ALSO NOTED WITH THE BAG VALVE MASK. RESPIRATORY FAILURE WAS MANAGED.

  Patient problems: Insufficient Information

  MAUDE report 20038021 ↗
• MalfunctionJun 28, 2024Crack; Crack

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN REPLACING AND UNPACKING THE FILTER, IT WAS FOUND THAT THE SPLICES WERE CRACKED AND NOT WORKING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634221 ↗
• MalfunctionMar 27, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THREE BREATHING CIRCUITS ALONG WITH THREE BREATHING CIRCUIT FILTERS DID NOT PASS THE LEAK TEST AS AN ABNORMALITY WAS DISCOVERED. THERE WAS A CRACK IN THE CIRCUIT, AND A LEAK WAS HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988723 ↗
• MalfunctionMar 27, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THREE BREATHING CIRCUIT ALONG WITH THREE BREATHING CIRCUIT FILTERS DID NOT PASS THE LEAK TEST AS AN ABNORMALITY WAS DISCOVERED. THERE WAS CRACKED IN THE CIRCUIT AND LEAK WAS HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988513 ↗
• MalfunctionMar 27, 2024Crack; Use of Device Problem; Crack; Use of Device Problem

  ACCORDING TO THE REPORTER, THREE BREATHING CIRCUIT ALONG WITH THREE BREATHING CIRCUIT FILTERS DID NOT PASS THE LEAK TEST AS AN ABNORMALITY WAS DISCOVERED. THERE WAS CRACKED IN THE CIRCUIT AND LEAK WAS HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988244 ↗
• MalfunctionJan 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT WAS UNDER ANESTHESIA FOR SURGERY AND THE TIDAL VOLUME OF THE ANESTHESIA MACHINE COULD NOT REACH THE SET VALUE. THE ANESTHESIA MACHINE SHOWED AIR LEAKAGE IN THE CIRCUIT AND THE PULSE OXYGEN DROPPED AND THE PATIENT COULD NOT VENTILATE NORMALLY. SEARCHED FOR THE CAUSE, REPLACING THE CIRCUIT AND OTHER RELATED CONSUMABLES, FAILED. AFTER REPLACING THE MOISTURE HEAT EXCHANGER, THE PATIENT'S TIDAL VOLUME REACHED THE SET VALUE, THE ANESTHESIA MACHINE STOPPED ALARMING, AND PULSE OXYGEN RECOVERED.

  Patient problems: Hypoventilation; Low Oxygen Saturation

  MAUDE report 18553402 ↗
• MalfunctionJan 18, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak

  ACCORDING TO THE REPORTER, A MOISTURE AND HEAT EXCHANGER WAS USED TO FILTER THE RESPIRATORY CIRCUIT BUT AFTER INTUBATION, THE MACHINE INDICATED AN AIR LEAK AND THE TIDAL VOLUME WAS INSUFFICIENT. IT WAS FOUND THAT THE FILTER-MOIST HEAT EXCHANGER HAD A CRACK THEREFORE IT WAS REPLACED.

  Patient problems: Hypoventilation

  MAUDE report 18539850 ↗
• MalfunctionJan 16, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A LEAK TEST WAS PERFORMED ON THE ANESTHESIA DEVICE AND IT DID NOT PASS. AFTER REPLACING THE CIRCUIT WITH A NEW ONE, THE LEAK TEST PASSED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522618 ↗
• MalfunctionNov 20, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE BREATHING SYSTEM FILTER HAD A LEAK AND SEAM WAS CRACKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172221 ↗
• MalfunctionNov 13, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE ANESTHESIA MACHINE DID NOT PASS THE LEAK TEST. WHEN THE BREATHING SYSTEM'S CIRCUIT FILTER WAS REPLACED, THE TEST WAS CLEARED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125165 ↗
• MalfunctionSep 19, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, LEAK TEST OF ANESTHESIA DEVICE WAS PERFORMED THREE TIMES AND FAILED PRIOR TO PATIENT ADMISSION. THE CIRCUIT WAS CHANGED AND PASSED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17775545 ↗
• MalfunctionSep 13, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE FILTER AND THE BAG HAD AN AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740802 ↗
• MalfunctionJun 14, 2023Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS POOR ADHESION OF THE ARTIFICIAL NOSE FILTER AND THE BACTERIA FILTER PART OF THE ARTIFICIAL NOSE CASE (HOUSING). WHEN THE CASE WAS HELD TO CHECK, THE ADHESION AROUND THE ENTIRE CIRCUMFERENCE HAD COME OFF. IT WAS ALSO STATED THAT THE DEVICE DID NOT PASS THE VENTILATOR LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17131679 ↗