Vapotherm PF-PLUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841737101369), received between Feb 28, 2022 and Aug 30, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

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.

• DeathAug 30, 2023Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT WAS RECEIVED AND LOGGED BY VAPOTHERM ON 04-AUGUST-2023 DEVICE SERIAL NUMBER (B)(6) GENERAL FAULT ALARM (GFA) WITH DOUBLE DASHES IN FIO2 (- - IN O2). VAPOTHERM RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT: MACHINE HAD BEEN IN USE FOR APPROXIMATELY 3 HOURS AT THE TIME OF THE EVENT. IT WAS NOTED TO BE HOOKED UP CORRECTLY. UNCLEAR IF THE PATIENT'S PRE EXISTING DECLINING CONDITION OR AN ALLEGED MACHINE MALFUNCTION CONTRIBUTED TO THE PATIENT DECLINE IN STATUS. THE UNIT GAVE A GFA (--) O2 ALARM, AT THAT TIME THE PATIENT WAS REMOVED FROM THE PF UNIT AND PLACED ON 100% O2 NON-REBREATHER BUT CONTINUED TO DESAT. THE PATIENT THEN WAS WITHDRAWN FROM MEDICAL CARE AND SOON PASSED AWAY.

  Patient problems: Low Oxygen Saturation; Respiratory Failure

  MAUDE report 17653221 ↗
• MalfunctionDec 21, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING COMPLAINT WAS RECEIVED AND LOGGED BY VAPOTHERM ON 21-NOV-2022. (B)(6), CUSTOMER REPORTED THAT THE DEVICE WAS RUNNING FOR TWELVE HOURS WHEN A "SYSTEM FAULT ERROR" ALARMED. THE ALARM THEN PROGRESSED TO AN ERROR CODE EC 54. CUSTOMER REPORTS THAT THE PATIENT THEN DESATURATED TO 72% AND WAS PLACED ON A NONREBREATHER MASK BY ICU STAFF AS INTERMITTENT THERAPY PRIOR TO THE ARRIVAL OF THE RESPIRATORY THERAPIST (RT). UPON ARRIVAL OF THE RT, THE PATIENT WAS PLACED ON BILEVEL TO RECOVER THEIR OXYGEN SATURATION. THE MEDICAL TEAM WAS UNABLE TO REINITIATE THE PRECISION FLOW. THE RT STATES THAT THERE WERE NO ADDITIONAL PRECISION FLOWDEVICES AVAILABLE FOR USAGE. AS AN ALTERNATE THERAPY THE RT PLACED THE PATIENT ON A HEATED HIGH FLOW NASAL CANULA (HHFNC), HOWEVER IT IS NOTED THAT THE STAFF WAS DELAYED IN LOCATING A TEMPERATURE CORD, WHICH IS NECESSARY FOR THIS ALTERNATE THERAPY. THE DELAY IN CARE TO PROPERLY IDENTIFY AND INITIATE ALTERNATE THERAPY, IS BEING CONSIDERED A SENTINEL EVENT BY THE ICU TEAM.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 16024246 ↗
• InjuryMar 7, 2022Obstruction of Flow; Obstruction of Flow

  EVENT WAS REPORTED TO VAPOTHERM ON 20-JAN-2022. WON'T OCCLUDE. UNIT IS CURRENTLY BEING HELD BY RISK MANAGEMENT AT HOSPITAL AND WILL NOT BE RELEASED UNTIL THE INVESTIGATION IS FINISHED. UNIT 38423 FAILED TO ALARM WHILE ON A PATIENT. THE CANNULA ON THE CIRCUIT TWISTED AND THE UNIT MADE A HISSING SOUND FROM THE DPC AREA. ATTEMPTED TO REPLICATE ON THE 25607 AND THIS UNIT EXPERIENCED THE SAME ISSUE. BLOCK TUBE ALARM UP TO 30LPM BUT AT 40LPM THERE WAS NO ALARM AND LEAKING SOUND FROM DPC AREA. USED THE SAME CIRCUIT ON A NEW UNIT AND THERE WERE NO ISSUES. UNABLE TO DETERMINE THE CAUSE - DPC OR PF UNIT. EVEN TRIED AT 39LPM AND THERE WAS A POP OFF SOUND AND ALARM. AT 40LPM THERE WAS NO POP AND THERE WAS AN AUDIBLE LEAK FROM THE DPC CARTRIDGE AREA. BASED ON THIS DESCRIPTION VAPOTHERM DETERMINED THIS WAS NOT A REPORTABLE INCIDENT AT THAT TIME. ON 9-FEB-2022 VAPOTHERM RECEIVED MEDWATCH REPORT WITH EMDR MEDWATCH NUMBER MW5107060 WITH THE FOLLOWING DESCRIPTION: "THE PATIENT WAS ON CONT BIPAP WAS PLACED ON HFNC TO EAT ON 40 LPM AND 100% FIO2. AT 1250 RN FOUND PATIENT WITH O2 SAT 13 UNRESPONSIVE AND TURNING PURPLE PER HER DOCUMENTATION. PLACED IMMEDIATELY ON NON-REBREATHER AND SATS CAME UP TO 89% A

  Patient problems: Hypoxia

  MAUDE report 13684390 ↗
• MalfunctionFeb 28, 2022No Apparent Adverse Event; No Apparent Adverse Event

  EVENT WAS REPORTED TO VAPOTHERM AS FOLLOWS ON (B)(6) 2021. "STAFF REPORTING A "WEIRD UNKNOWN NOISE" FROM THE DEVICE, THERE WERE NO ALARMS, THE DEVICE DID NOT SHUT DOWN AND CONTINUED TO RUN WITH OUT ERROR. THE DOCTOR OPTED TO REMOVE THE PATIENT FROM THE DEVICE WHICH WAS RUNNING AT 40 L/MIN, 100% FIO2, 37°C TO PLACE THE PATIENT ON BIPAP, THE PATIENT IMMEDIATELY DESATTED, THE PATIENTS CURRENT CONDITION IS UNKNOWN. THE CLINICAL ENGINEER CONFIRMED THIS INCIDENT AND REPORTED THE DETAILS, HE WAS UNABLE TO GET A BETTER DESCRIPTION OF THE NOISE THAT WAS MADE BY THE UNIT." BASED ON THIS DESCRIPTION VAPOTHERM DETERMINED THIS WAS NOT A REPORTABLE INCIDENT AT THAT TIME. MEDWATCH 2100630000-2022-8001 BY (B)(6) MEDICAL CENTER WAS RECEIVED BY VAPOTHERN ON (B)(6) 2022 WITH THE FOLLOWING DESCRIPTION. "THE INTENSIVIST WAS IN THE PATIENT ROOM WHEN SHE HEARD THE VAPOTHERM MAKE A STRANGE SOUND WHILE ON THE PATIENT. THERE WAS NO AUDIBLE ALARM AND THE DEVICE HAD POWER TO IT. THE PATIENT STARTED TO DESATURATE INTO THE S0'S AND IT WAS SUSPECTED AT THAT TIME THAT THERE WAS A CHANGE IN PRESSURE FROM THE DEVICE TO THE PATIENT. THE PATIENT WAS REMOVED FROM VAPOTHERM AND PLACED ON BIPAP AND OXYGEN SATURATIONS IM

  Patient problems: Hypoxia

  MAUDE report 13624631 ↗