Synclara Cough System M08575Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00887761984554), received between Jul 10, 2024 and Aug 31, 2026 — classified as 1 death, 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Crack” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumonia

  MAUDE report 50531460 ↗
• MalfunctionAug 27, 2026Crack

  Baxter received a report that SYNCLARA SYSTEM, NON-FT SW,HC,NA had cracked filter. This occurred at home before use. There was no patient injury or death reported with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465978 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50044710 ↗
• MalfunctionJul 3, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25707344 ↗
• MalfunctionJun 24, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611556 ↗
• MalfunctionJun 16, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523314 ↗
• MalfunctionJun 16, 2026Crack

  BAXTER RECEIVED A REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD FILTER BROKEN. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523249 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CYANOTIC EPISODE AFTER SYNCLARA THERAPY WAS PERFORMED. IT WAS NOTED THAT THE CUSTOMER WAS TRAINED DURING INITIAL SET UP TO PAUSE AFTER 5 BREATHS; HOWEVER, IT WAS REPORTED DURING THE SESSION THAT THE PATIENTS¿ FACE TURNED BLUE THE CUSTOMER COMPLETED 10 BREATHS IN A ROW. TWO DAYS LATER THE PATIENT HAD A FEVER AND A COLD WHERE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE IFU OF THE DEVICE MENTIONS THAT THE USE OF A FACE MASK MAY RESULT IN DISCOMFORT, VOMITING, OR BREATHLESSNESS IN SOME PATIENTS. CLOSE SUPERVISION THROUGHOUT THE TREATMENT IS NECESSARY WHEN THIS PRODUCT IS USED BY CHILDREN OR PATIENTS WITH PHYSICAL LIMITATIONS OR IMPAIRED COGNITIVE ABILITIES. THERE WAS NO REPORT OF MALFUNCTION OF THE SYNCLARA DEVICE. THE DEVICE REMAINS WITH THE PATIENT, WHO WILL RESUME ITS USE, DECREASING THE THERAPY CYCLES PERFORMED BEFORE A BREAK. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cyanosis; Respiratory Tract Infection

  MAUDE report 25144135 ↗
• MalfunctionApr 8, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW, HC, NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823944 ↗
• MalfunctionFeb 26, 2026Crack

  ON 02-FEB-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM SERVICE, NON-FT SW,HC,NA (PRODUCT CODE M08575A, SERIAL NUMBER (B)(6)), HAD A CRACKED FILTER. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457463 ↗
• MalfunctionFeb 17, 2026Crack

  ON 26-JAN-2026, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6)), HAD CRACKED FILTER ON THE SYN CIRC FILTER. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368780 ↗
• MalfunctionFeb 9, 2026Crack

  ON 15-JAN-2026, A NURSE CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6)), HAD FILTER CRACKED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24297860 ↗
• MalfunctionJan 21, 2026Crack

  ON 06-JAN-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6) ), FILTER WAS CRACKED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133849 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PEDIATRIC PATIENT¿S OXYGEN DESATURATED WITH A SYNCLARA COUGH SYSTEM AND EVENTUALLY DEVELOPED PNEUMONIA. ON THE DAY OF THE EVENT, THE TRAINER ADJUSTED THE PATIENT¿S PRESSURES ON THE SYNCLARA DEVICE FROM +/-30 TO +/-40. AFTER THE TRAINER LEFT, THE PATIENT¿S SPO2 DECREASED DOWN INTO THE 70¿S(%). THE PARENTAL CAREGIVERS PLACED THE PATIENT ON THEIR HOME O2 DEVICE AT 2-4 LITERS PER MINUTE (AVERAGING AT 3 LPM) TO MAINTAIN THE MAINTAIN THE PATIENT¿S SPO2; HOWEVER, THE PATIENT CONTINUED TO HAVE TROUBLE KEEPING THEIR SPO2 WITHIN THE ¿NORMAL RANGES.¿ THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH PNEUMONIA AND IS WAS PUT ON A VENTILATOR AFTER AN UNKNOWN AMOUNT OF TIME. EIGHT DAYS AFTER EVENT ONSET, THE PATIENT WAS DISCHARGED HOME. THE PATIENT IS CURRENTLY NOT USING THE SYNCLARA DEVICE. FURTHERMORE, THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation; Pneumonia

  MAUDE report 23883036 ↗
• MalfunctionDec 1, 2025Crack; Crack

  ON 05-NOV-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW, HC, NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6)), HAD FILTER BROKEN. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682731 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PEDIATRIC PATIENT DESATURATED DURING USE WITH A SYNCLARA COUGH SYSTEM. THE PATIENT¿S PARENTAL CAREGIVER RECEIVED THE SYNCLARA DEVICE AND USED IT THREE TIMES. EACH TIME THE PATIENT¿S ¿OXYGEN SATURATION DROPPED SIGNIFICANTLY.¿ THE PATIENT¿S SPO2 DROPPED THE FIRST TIME TO 20%, THE SECOND TIME WAS 36% AND THE THIRD TIME WAS 28% DURING SYNCLARA THERAPY. DURING EACH EVENT, THE PATIENT ¿TURNED VERY PURPLE WITHIN SECONDS OF STARTING THERAPY.¿ ADDITIONALLY, PER THE PATIENT¿S CAREGIVER, THE PATIENT IS ¿GOING THROUGH ALL 15 CYCLES WITHOUT PAUSING.¿ ONCE THE MASK WAS REMOVED, ¿THE PATIENT RECOVERED RATHER QUICKLY BACK TO THEIR BASELINE SPO2 OF 97-98% ON ROOM AIR.¿ ALTHOUGH THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION, THE EVENT IS CONSIDERED TEMPORARILY LIFE-THREATENING DUE TO THE SIGNIFICANT DROP IN OXYGEN SATURATION COUPLED WITH CYANOSIS (INDICATING DEOXYGENATED HEMOGLOBIN). THE DEVICE INSTRUCTIONS FOR USE STATE: ¿DURING THE PAUSE STAGE, HAVE THE PATIENT BREATHE NORMALLY. DO THE NUMBER OF THERAPY CYCLES (INHALE-EXHALE-PAUSE) AS RECOMMENDED BY THE PHYSICIAN OR BY THE PATIENT GROUP: (FOR CHILDREN¿3-5 CYCLES)¿. THE CAUSE OF THE EVENT IS LIKELY MULTIFACTORIAL AND RELATED TO

  Patient problems: Low Oxygen Saturation

  MAUDE report 23004232 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DESATURATED WHILE UTILIZING A SYNCLARA COUGH SYSTEM. A BAXTER RESPIRATORY TRAINER (BRT) HAD COMPLETED THE SYNCLARA SET UP FOR THE PATIENT WITH THE PARAMETERS RECEIVED. THE SYNCLARA WAS SET AT ¿THE LOWEST SETTING OF +/-10¿, THE PATIENT TURNED RED AND THEIR SPO2 READING ¿DIPPED INTO THE 70¿S.¿ THE BRT WAS UNABLE TO DO AN ACCURATE EVALUATION OF THE PATIENT¿S RECOVERY TIME OR HOW WELL THEY TOLERATED TREATMENT DUE TO THE PATIENT¿S CAREGIVERS BECOMING ¿NERVOUS AND ANXIOUS.¿ THE CAREGIVERS IMMEDIATELY PUT THE PATIENT ON OXYGEN, GRABBED A STETHOSCOPE, AND STARTED DOING MANUAL CHEST PHYSIOTHERAPY ON THE PATIENT. THE BRT WAS NOT CONVINCED THE WAVEFORM ON THE SPO2 MONITOR IS ACCURATE DUE TO THE CAREGIVERS ¿MESSING¿ WITH THE PATIENT. IT TOOK APPROXIMATELY FIVE MINUTES FOR THE SPO2 TO ¿RECOVER¿ BACK TO THE ¿PRESCRIBED RANGE OF 85-90%.¿ THE CAREGIVERS REQUESTED THE SYNCLARA DEVICE REMAIN IN THE PATIENT¿S HOME AND TO HAVE THE BRT RETURN THE NEXT WEEK TO ¿TRY THE DEVICE AGAIN.¿ THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22874686 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CHILD'S OXYGEN SATURATION LOWERED WITH THE USE OF A SYNCLARA COUGH SYSTEM. THE PARENTAL CAREGIVER WAS TRAINED ON THE USE OF THE SYNCLARA DEVICE. THE CAREGIVER PERFORMED THE INITIAL SET UP OF THE SYNCLARA AND THE CHILD TOLERATED THERAPY. AFTER AN UNSPECIFIED AMOUNT OF TIME WHILE THE CHILD WAS SLEEPING, THEIR SPO2 DROPPED (O2 LEVEL NOT REPORTED). THE CAREGIVER PLACED THE CHILD ON 5LPM 02 PER NASAL CANNULA AND THE CHILD'S SP02 INCREASED TO 89%. THE CAREGIVER THEN WOKE THE CHILD UP AND THE SPO2 INCREASED TO "GREATER THAN 93%." THE CAREGIVER REPORTEDLY PUT THE CHILD ON 3LPM OF O2 VIA NASAL CANNULA AND THE "SPO2 REMAINED AT 93% OVERNIGHT." ACCORDING TO THE CAREGIVER, THE CHILD NO LONGER REQUIRED OXYGEN AND IS UNSURE IF THE O2 LEVEL DROPPING WAS A RESULT OF THE SYNCLARA USE OR FROM THE PATIENT¿S RESIDUAL ILLNESS. THE CAREGIVER ALSO REPORTED THAT THE PATIENT STARTED A NEW ANTIBIOTIC (NAME AND DOSE NOT REPORTED) THAT SAME DAY. THE CAREGIVER PLANNED TO DISCUSS THE FUTURE USE OF THE SYNCLARA DEVICE WITH THE CHILD'S HEALTHCARE PROVIDER AND WILL RESUME USE PER PHYSICIAN DIRECTION. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME

  Patient problems: Low Oxygen Saturation

  MAUDE report 22725354 ↗
• MalfunctionJul 28, 2025Sparking; Sparking

  BAXTER RECEIVED A REPORT STATING THAT SYNCLARA SYSTEMPOWER CORD PRONG WAS BENT, CAUSING THE PORWERCORD TO SPARK AT THE WALL OUTLET WHEN PLUGGED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22633412 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT A PATIENT EXPERIENCED PNEUMOTHORAX COINCIDENT WITH THE USE OF A SYNCLARA THERAPY DEVICE. THE PATIENT WAS HOSPITALIZED FOR PNEUMOTHORAX PRIOR TO THE LAST TRAINING VISIT FOR THE SETUP OF A PATIENT¿S NEW SYNCLARA DEVICE. THE CAUSE OF THE PNEUMOTHORAX WAS UNKNOWN. THE PATIENT WAS USING SETTINGS OF +/-50, +5 PAP, 1.4 SECOND I-TIME, 1.8 SECOND E TIME, 1 SECOND PAUSE TIME, 20 CYCLES AT THE TIME OF INCIDENT. THE PATIENT WAS HOSPITALIZED FOR APPROXIMATELY ONE WEEK. WHEN ADMITTED, THE PATIENT WAS PLACED ON OXYGEN VIA FACE A MASK. THAT EVENING, THE PATIENT WAS PLACED BACK ON THEIR NON-BAXTER POSITIVE AIRWAY PRESSURE (PAP) MACHINE WITH LOWER TIDAL VOLUMES WHILE THEY SLEPT. THE NEXT MORNING, THEY WERE PLACED ON ROOM AIR. WHILE HOSPITALIZED, THEY RECEIVED XRAYS TWICE PER DAY. THEY ALSO NOTED A CT SCAN PERFORMED WHILE HOSPITALIZED. AFTER DISCHARGE, THEY HAD BEEN FOLLOWING UP WITH THEIR PULMONOLOGIST WEEKLY FOR AN XRAY. THE LAST XRAY, THE PNEUMOTHORAX WAS STILL PRESENT HOWEVER MUCH SMALLER. THE PATIENT WAS CLEARED BY THEIR PULMONOLOGIST AND HAD BEEN USING THEIR SYNCLARA WITH LOWER PRESSURES. AT THE TIME OF THIS REPORT, THE PATIENT WAS CONTINUING WITH THE DEVICE THERAPY. T

  Patient problems: Pneumothorax

  MAUDE report 22420856 ↗
• InjuryJul 3, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN ACUTE ILLNESS (RHINOVIRUS AND ENTEROVIRUS) AND USED THE SYNCLARA COUGH SYSTEM TO CLEAR SECRETIONS; HOWEVER, THE DEVICE PROVIDED A 003 ERROR THAT WAS UNABLE TO BE RESOLVED (UNABLE TO CLEAR WITH TROUBLESHOOTING). THE PATIENT¿S OXYGEN SATURATION DROPPED, AND THE PATIENT WAS BROUGHT TO THE HOSPITAL. THE PATIENT HEALTHCARE PROVIDED INFORMED BAXTER THAT HAD THE SYNCLARA WORKED PROPERLY, THE PATIENT WOULD HAVE BEEN ABLE TO CLEAR THEIR SECRETIONS, WOULD NOT HAVE EXPERIENCED OXYGEN DESATURATION AND THEREFORE WOULD NOT HAVE REQUIRED HOSPITALIZATION. NO DETAILS OF THE TREATMENTS PERFORMED IN THE HOSPITAL WERE PROVIDED. AT THE TIME OF THIS REPORT, THE PATIENT HAS SINCE RETURNED HOME FROM THE HOSPITAL AND HAS RECEIVED A REPLACEMENT SYNCLARA DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22394193 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED ASPIRATION PNEUMONIA WITH LOW OXYGEN SATURATION AFTER USE OF A SYNCLARA COUGH SYSTEM. REPORTEDLY AFTER APPROXIMATELY ONE HOUR AFTER THE PATIENT COMPLETED SYNCLARA DEVICE THERAPY, THE PATIENT BEGAN TO BREATHE HEAVILY, AND THEIR OXYGEN SATURATION MEASURED 80% SPO2. THE PATIENT WAS TAKEN TO THE HOSPITAL AND WAS ADMITTED FOR ¿DEVELOPING ASPIRATION PNEUMONIA.¿ THIS DIAGNOSIS WAS NOT CONFIRMED TO BE ATTRIBUTED TO THE USE OF THE SYNCLARA DEVICE. IN THE HOSPITAL THE PATIENT WAS PLACED ON BIPAP THE FIRST TWO DAYS AND THEN RETURNED TO ROOM AIR, NO ADDITIONAL TREATMENT WAS PROVIDED. IT IS ALSO NOTED THAT THE PATIENT RECEIVED 6L OXYGEN WHILE HOSPITALIZED; HOWEVER, IT IS UNKNOWN IF THE OXYGEN WAS USED AS SIMULTANEOUS SUPPLEMENTATION WITH THE BIPAP DEVICE OR SINGULARLY. FIVE DAYS AFTER ADMISSION TO THE HOSPITAL THE PATIENT WAS DISCHARGED. ALTHOUGH THE SYNCLARA DEVICE WAS NOT IN USE AT THE TIME OF THE DESATURATION, IT IS UNDETERMINED AT THIS TIME WHETHER THE EARLIER TREATMENT CONTRIBUTED TO THE ASPIRATION PNEUMONIA. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE SYNCLARA DEVICE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Aspiration Pneumonitis; Low Oxygen Saturation

  MAUDE report 22371233 ↗
• MalfunctionJun 27, 2025Crack; Crack

  BAXTER RECEIVED A REPORT STATING THAT SYNCLARA FILTER WAS CRACKED. THE DEVICE WAS LOCATED AT THE HOME AND OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22347451 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PEDIATRIC PATIENT DESATURATED WHILE USING A SYNCLARA VEST. DURING SYNCLARA USE, THE PATIENT¿S OXYGEN SATURATION LEVEL DROPPED INTO THE 50¿S. SYNCLARA THERAPY WAS STOPPED. THE PATIENT WAS PLACED ON THEIR HOME VENTILATOR WITH SUPPLEMENTAL OXYGEN 1LPM BY THE HOME NURSE. THE PATIENT¿S SPO2 QUICKLY INCREASED ABOVE 90%. AFTER RETRAINING, THE PATIENT HAD NO FURTHER DESATURATION EPISODES. THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22123067 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DESATURATED WHILE USING A SYNCLARA COUGH SYSTEM. THE PATIENT¿S OXYGEN SATURATION DROPPED TO 60% WHEN USING THE SYNCLARA COUGH SYSTEM. THE PATIENT¿S PARENTAL CAREGIVER PROVIDED SUPPLEMENTAL OXYGEN, AND THE PATIENT RECOVERED WITHOUT MEDICAL ATTENTION REQUIRED. ADDITIONALLY, THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22081757 ↗