Vapotherm PF-UNITRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841737100140), received between Aug 27, 2019 and Dec 21, 2023 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathDec 21, 2023Device Alarm System; Device Alarm System

  THE FOLLOWING COMPLAINT WAS RECEIVED AND LOGGED BY VAPOTHERM ON (B)(6) 2023. DEVICE SERIAL NUMBER (B)(6). THE PATIENT INCIDENCE WAS REPORTED TO VAPOTHERM ON THE PRECISION FLOW UNIT WITH SERIAL NUMBER (B)(6). THE PATIENT WAS PLACED ON A NON REBREATHER MASK AND HAD A BLOOD OXYGEN SATURATION IN THE 80S. THE PATIENT WAS PLACED ON THE PRECISION FLOW UNIT WITH BLOOD OXYGEN SATURATION IN "LOW 80S". THE UNIT WAS BEING OPERATED AT 100% FIO2 AT 40 LPM (MAX) FLOW SETTING. AFTER TREATMENT ON THE UNIT FOR A PERIOD OF TIME IT WAS INITIALLY STATED THAT THE UNIT ALARMED FOR A IN THE FIO2 SETTING WITH A GENERAL FAULT ALARM. THERE WAS NO FLOW FROM THE DEVICE WHILE THE ALARM WAS PRESENT. SUBSEQUENTLY, THE PATIENT'S O2 SATURATION DROPPED INTO THE 70'S AND THE PATIENT WAS PLACED ON A NON-REBREATHER MASK. PATIENT WAS DNR/DNI AND THE PATIENT'S FAMILY DECLINED PLACING THE PATIENT ON A MORE AGGRESSIVE ALTERNATE THERAPY. THE PATIENT'S BLOOD O2 SATURATION DECLINED FURTHER AND THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 18377193 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT WAS RECEIVED AND LOGGED BY VAPOTHERM ON (B)(6) 2022 WHICH IS THE SAME DATE OF THE REPORTED MEDWATCH INCIDENT. "RT CALLED TO ROOM FOR RAPID RESPONSE/CODE BLUE. UPON ARRIVING PATIENT WAS DESATTING, THEN CPR WAS STARTED SOON AFTER AND PT INTUBATED. PT STARTED ON VAPOTHERM AT 08:57. DESAT AND ALARM STATUS APPEARED AT SOMETIME AFTER 11:50 AM. PF UNIT HAD GENERAL FAULT ICON LIT, -- IN TEMP. FIELD, 20LPM, 0.5 IN O2 FIELD (UNSURE IF THIS IS ACCURATE, RT WAS NOT IN ROOM WHEN THIS REPORT WAS TAKEN). RT MANAGER UNSURE IF PF UNIT WAS AUDIBLY ALARMING AS WELL. NO CIRCUIT OR H2O BAG SAVED. POSSIBLE OUT OF WATER ISSUE. I ARRIVED ONSITE TODAY TO TEST UNIT, USING GOOD HI-FLOW CIRCUIT, UNIT PASSED ALL USE TEST WITH NO ALARMS TRIGGERED. WILL SEND TO BIOMED TO RUN FOR SHIFT TO SEE IF LATENT ALARM TRIGGERS AT ANY TIME. RT MANAGER WILL GATHER MORE INFORMATION AND WE WILL MEET AGAIN TO DISCUSS." MEDWATCH (B)(4) WAS FILED BY THE CUSTOMER WITH THE FOLLOWING DESCRIPTION THAT WAS RECEIVED BY VAPOTHERM ON (B)(6) 2022. "HIFLOW NASAL CANNULA 100% OXYGEN (40L/MIN) - MACHINE SCREEN DISPLAYED AN ERROR MESSAGE (SCREEN WAS BLACK, SHOWING ONLY THE CAUTION SYMBOL) WITH NO OXYGEN BEING DELIVERED

  Patient problems: Respiratory Arrest

  MAUDE report 14804346 ↗
• DeathNov 22, 2019Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Moisture or Humidity Problem

  VAPOTHERM'S COMPLIANCE HOT-LINE WAS USED BY A PATIENTS FAMILY MEMBER TO REPORT AN EVENT THAT OCCURRED IN (B)(6) 2018. THE REPORT DESCRIBES MISUSE OF VAPOTHERM'S DEVICE RESULTING IN THE DEATH OF THE PATIENT. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME DUE TO CONFIDENTIALITY CONTROLS ON THE REPORTING TOOL. THE FAMILY MEMBERS REPORT IS AS FOLLOWS. "HELLO, I NEED TO REPORT THAT THE WRONGFUL USE OF THE VAPOTHERM UNIT CAUSED MY GRANDDAUGHTERS DEATH. (B)(6) 2018 AT (B)(6) HOSPITAL IN (B)(6) UNDER THE CARE OF DR. (B)(6). THE VAPOTHERM WAS SETUP WITH THE WRONG TUBING. CORRECT TUBING COULD NOT BE FOUND TO REPLACE IT WITH. THE TUBING USED TO DELIVER HER BREATHING TREATMENT WAS TOO SHORT. MY GRANDDAUGHTER HAD TO LAY PERFECTLY FLAT AND STILL OR LIQUID WOULD GO IN HER NOSE. THE ENTIRE TIME SHE WAS ON THE VAPOTHERM THE TUBING WAS NEVER REMOVED OR CHANGED. THE LIQUID BREATHING MEDICATION DID NOT EVAPORATE PROPERLY. AFTER HOURS OF CONDENSATION AND LIQUID MEDICATION BUILDING UP A NURSE UNKNOWINGLY PICKED UP THE TUBING POURING ALL THE LIQUID INTO MY GRANDDAUGHTERS NOSE AND CAUSING A NASAL ASPIRATION THAT SHE COULD NOT OVERCOME. SHE WAS 6 MONTHS OLD. I HAVE READ THE VAPOTHERM WARNINGS AGAINST

  Patient problems: Aspiration/Inhalation; Death

  MAUDE report 9362547 ↗
• MalfunctionAug 27, 2019Loss of Power; Failure to Power Up; No Flow

  HOSPITALIZED COPD PT WAS ON VAPOTHERM PRECISION FLOW DEVICE WHEN NURSING STAFF DISCOVERED THE PT WAS HYPOXIC WITH ASSOCIATED ALTERED MENTAL STATUS REQUIRING IMMEDIATE INTERVENTION. IT WAS NOTED BY NURSING STAFF RESPONDING TO THE CODE THAT THE VAPOTHERM HAD SHUT OFF. THE DEVICE WASN'T BEEPING PRIOR TO THE EVENT (AS PER DISCUSSION WITH THE NURSE WHO WAS IN THE ROOM PRIOR TO THE EVENT AND THE FAMILY WHO HAD ALSO BEEN PRESENT IN THE ROOM BEFORE AND DURING THE EVENT). THE MACHINE WOULD NOT IMMEDIATELY TURN BACK ON. THE MACHINE WAS TAKEN OUT OF SERVICE AND TURNED BACK ON. IT APPEARED TO BE WORKING AGAIN. WE INSPECTED THE WALL PLUGS AND THEY WERE FUNCTIONING PROPERLY. WE RAN THE MACHINE AGAIN TO TRY TO SHUT IT OFF AND IT SEEMED TO BE OPERATING FINE. WE UNPLUGGED IT AND IT SOUNDED AN AUDIBLE ALERT FOR SOMETIME BEFORE SHUTTING DOWN. WE DO NOT KNOW WHY THIS UNIT SHUTDOWN WITH NO WARNING WHILE IN USE ON A PT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Hypoxia; Neurological Deficit/Dysfunction

  MAUDE report 8939799 ↗