Skip to content

Life2000 BT-20-0002Recalls & reported problems

Hill-Rom Services Pte. Ltd. · LIFE2000 VENTILATOR PACKAGED · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Hill-Rom Life2000 home ventilator is a breathing machine for home use. Many of the 112 reports describe accessories that do not work with the unit and tubing that tears. The reports include 37 injuries and 3 deaths. Reports fell to 1 in the last 12 months from 12 in the previous 12 months. One open recall, started in December 2024, covers a charger problem that can trigger an alarm and stop the ventilator.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
112
Deaths reported
3
Injuries reported
37
Recalls naming it
1

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00887761978201), received between Sep 8, 2022 and Nov 25, 2025 — classified as 3 deaths, 37 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (49 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 3 reportsDec 2023: 6 reportsJan 2024: 2 reportsFeb 2024: 5 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 2 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 3 reportsNov 2024: 2 reportsDec 2024: 1 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 4 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520266
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Dec 20, 2024Open, Classified

    There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.

    Z-0884-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Accessory Incompatible49
  • Material Split, Cut or Torn25
  • Appropriate Device Problem Term/Code Not Available13
  • Adverse Event Without Identified Device or Use Problem11
  • No Audible Alarm4
  • Disconnection2
  • Sparking2
  • Use of Device Problem2

Patient problems

  • Low Oxygen Saturation54
  • No Clinical Signs, Symptoms or Conditions40
  • Dyspnea4
  • Abnormal Blood Gases2
  • Chest Pain2
  • Confusion/ Disorientation2
  • Dizziness2
  • Pneumothorax2

Recent adverse event reports

The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.

  • DeathNov 25, 2025Sensing Intermittently; Sensing Intermittently

    IT WAS REPORTED A PATIENT ALLEGEDLY PASSED AWAY WHILE USING A LIFE2000 VENTILATOR. REPORTEDLY WHILE HOSPITALIZED THE DEVICE ¿EITHER STOPPED RUNNING OR RAN ONLY INTERMITTENTLY¿ WHILE THE PATIENT WAS CONNECTED TO THE DEVICE. IT WAS REPORTED THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF PASSING. PER THE DEATH CERTIFICATE THE CAUSE OF DEATH LISTED WAS LISTED AS ¿ACUTE-ON-CHRONIC RESPIRATORY FAILURE¿ AND ¿ANOXIC BRAIN INJURY DUE TO PRE-HOSPITAL CARDIAC ARREST.¿ BAXTER¿S INVESTIGATION IS ONGOING INTO THE SEQUENCE OF EVENTS FROM THE PATIENT¿S INITIATION OF LIFE 2000 THERAPY TO THE PATIENT¿S DEATH, INCLUDING ANY SERVICING/MAINTENANCE PERFORMED ON THE ASSOCIATED LIFE 2000 DEVICE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Cardiac Arrest

    MAUDE report 23647138 ↗
  • MalfunctionJul 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE L2K SERVICED VENTILATOR POWER CORD FRAYED AND HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER ALREADY COMMUNICATED THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY: PATIENT TALKED TO CLINICAL TEAM TO TROUBLESHOOT ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22485145 ↗
  • InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT DEVELOPED A SINUS INFECTION IN CONJUNCTION WITH A LIFE200 DEVICE. THE NURSE PRACTITIONER MADE A HOME VISIT AND PRESCRIBED A COURSE OF UNSPECIFIED ANTIBIOTICS. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE INFECTION DID NOT CLEAR UP. ANOTHER COURSE OF ANTIBIOTICS WAS ADDED WITH AUGMENTIN. REPORTEDLY, ¿SEVERAL COURSED OF ANTIBIOTICS¿ WERE REQUIRED TO ¿CLEAR THE INFECTION.¿ THERE WAS NO REPORT OF A DEVICE MALFUNCTION. PATIENT USES ¿TWO VENTS AND TWO COMPRESSORS.¿ FURTHERMORE, THE PATIENT WAS ASKED IF THEY WERE ABLE TO COMPLETE THE RECOMMENDED SUPPLY MAINTENANCE OF NASAL INTERFACE/COMBO TUBING, AND THE PATIENT STATED THAT ¿DUE TO TRAINERS¿ DISTANCE FROM THEM, AND THE INCONSISTENCY OF TRAINING SCHEDULES, THEY DID NOT REPLACE THE DEVICE SUPPLIES PER MAINTENANCE¿. PATIENT STATED THEY WERE ¿WASHING THE INTERFACE¿. THE PATIENT DECIDED TO RETURN THE DEVICES AS THEY DECIDED TO DISCONTINUE ITS USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Unspecified Infection

    MAUDE report 22324248 ↗
  • InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT DEVELOPED A SINUS INFECTION IN CONJUNCTION WITH A LIFE200 DEVICE. THE NURSE PRACTITIONER MADE A HOME VISIT AND PRESCRIBED A COURSE OF UNSPECIFIED ANTIBIOTICS. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE INFECTION DID NOT CLEAR UP. ANOTHER COURSE OF ANTIBIOTICS WAS ADDED WITH AUGMENTIN. REPORTEDLY, ¿SEVERAL COURSED OF ANTIBIOTICS¿ WERE REQUIRED TO ¿CLEAR THE INFECTION.¿ THERE WAS NO REPORT OF A DEVICE MALFUNCTION. PATIENT USES ¿TWO VENTS AND TWO COMPRESSORS.¿ FURTHERMORE, THE PATIENT WAS ASKED IF THEY WERE ABLE TO COMPLETE THE RECOMMENDED SUPPLY MAINTENANCE OF NASAL INTERFACE/COMBO TUBING, AND THE PATIENT STATED THAT ¿DUE TO TRAINERS¿ DISTANCE FROM THEM, AND THE INCONSISTENCY OF TRAINING SCHEDULES, THEY DID NOT REPLACE THE DEVICE SUPPLIES PER MAINTENANCE¿. PATIENT STATED THEY WERE ¿WASHING THE INTERFACE¿. THE PATIENT DECIDED TO RETURN THE DEVICES AS THEY DECIDED TO DISCONTINUE ITS USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Unspecified Infection

    MAUDE report 22323287 ↗
  • MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE L2K SERVICED VENTILATOR POWER CORD HAD COPPER WIRES EXPOSED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21696927 ↗
  • InjuryMar 19, 2025Disconnection; Disconnection

    IT WAS REPORTED A PATIENT EXPERIENCED SHORTNESS OF BREATH AND CHEST DISCOMFORT WHEN THE TUBING OF A LIFE2000 DEVICE DISCONNECTED. THE PATIENT NOTED THE COMBO TUBING WAS NOT CONNECTED TO THE BREATHE PILLOWS INTERFACE. THE PATIENT WAS NOT CLEAR HOW LONG THE TUBING HAD BEEN DISCONNECTED. THE PATIENT DID NOT HAVE A PULSE OXIMETER TO CHECK THEIR OXYGEN SATURATION. THE PATIENT RECONNECTED THE TUBING AND THEIR SYMPTOMS RESOLVED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Chest Pain; Dyspnea

    MAUDE report 21649273 ↗
  • InjuryMar 19, 2025Disconnection; Disconnection

    IT WAS REPORTED A PATIENT EXPERIENCED ¿UNCOMFORTABLE FEELING IN THE CHEST¿ WHEN THE TUBING OF A LIFE2000 DEVICE DISCONNECTED. THE PATIENT NOTED THE COMBO TUBING WAS NOT CONNECTED TO THE BREATHE PILLOWS INTERFACE. THE PATIENT RECONNECTED THE TUBING AND THEIR SYMPTOMS RESOLVED. ADDITIONALLY, THE PATIENT USING THE LIFE2000 IN BED WITH AN UNSPECIFIED SLEEP APNEA DEVICE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Chest Pain

    MAUDE report 21649272 ↗
  • MalfunctionMar 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE L2K SERVICED VENTILATOR POWER CORD HAD COPPER WIRES EXPOSED. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. THE REPORTER ALREADY COMMUNICATED THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21646563 ↗
  • InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT EXPERIENCED ¿LETHARGIC AND UNRESPONSIVE¿ AND SPO2 WAS 70% WHILE RECEIVING OXYGEN THERAPY ON THE LIFE2000. THE DAY PRIOR TO THE EVENT THE PATIENT¿S FAMILIAL CAREGIVER NOTED THE PATIENT HAD ¿INCREASED SLEEPINESS AND CONFUSION¿. THE FOLLOWING DAY, THE PATIENT WAS WEARING THE LIFE2000 WITH 4 LPM OXYGEN BLEED IN THROUGH HER HOME OXYGEN CONCENTRATOR (BRAND/MODEL UNKNOWN). THE PATIENT BECAME LETHARGIC AND UNRESPONSIVE AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED. PER THE CAREGIVER, THE OXYGEN CONCENTRATOR WAS WORKING PROPERLY AND NO DROP IN THE FLOW METER WAS NOTED. THERE WAS NO ALLEGED DEVICE MALFUNCTION OF THE LIFE2000, AND NO AUDIBLE OR VISUAL ALERTS WERE REPORTED. UPON ARRIVAL OF EMS, THE PATIENT¿S SPO2 WAS 70% AND THE PATIENT WAS PLACED ON SUPPLEMENTAL OXYGEN VIA FACE MASK AND TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS PLACED ON BIPAP IN THE EMERGENCY ROOM AND ARTERIAL BLOOD GAS SHOWED A CO2 LEVEL OF 112. THE PATIENT WAS HOSPITALIZED AND TREATMENT ALTERNATED BETWEEN BIPAP AND HIGH FLOW O2.SIX DAYS LATER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE FOLLOWING DAY THE PATIENT WAS ADMITTED INTO HOSPICE CARE. THE PATIENT IS CURRENTLY USING THE LIFE2000 AND TOLERA

    Patient problems: Confusion/ Disorientation; Lethargy; Loss of consciousness; Low Oxygen Saturation; Sleepiness/Drowsiness/Somnolence

    MAUDE report 21256651 ↗
  • MalfunctionJan 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21079966 ↗
  • DeathDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED FROM THE PATIENT¿S CAREGIVER, THE PATIENT DIED IN CONJUNCTION WITH THE LIFE2000. ON AN UNREPORTED DATE THE PATIENT WAS HOSPITALIZED FOR UNKNOWN CAUSE. WHILE IN THE INTENSIVE CARE UNIT, THE PATIENT DIED. THE PATIENT UTILIZED THE DEVICE ¿24 HOURS A DAY, SEVEN DAYS A WEEK¿ ACCORDING TO THE PATIENT'S CAREGIVER. NO DESATURATIONS, ERROR CODES OR ALARMS WERE REPORTED DURING THE PATIENT'S USE OF THE LIFE2000. AT THE TIME OF THE PATIENT¿S DEATH, THE PATIENT WAS NOT CONNECTED TO THE LIFE2000. THE CAUSE OF DEATH WAS NOT REPORTED; NOR WAS IT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 20929714 ↗
  • MalfunctionNov 26, 2024No Audible Alarm; No Audible Alarm

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE DEVICE WOULD NOT ALARM LOW GAS PRESSURE WHEN DISCONNECTED FORM VENT. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20789597 ↗
  • InjuryNov 22, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS ALLEGED THAT THE PATIENT¿S LIFE2000 DEVICE ALARMED AND STOPPED WORKING AND THE PATIENT EXPERIENCED OXYGEN DESATURATION. AT THE TIME OF THE REPORTED EVENT, THE PATIENT STATED THE LIFE2000 HAD A YELLOW ALARM THAT TURNED RED, AND THE DEVICE STOPPED GIVING BREATHS. THE PATIENT TRIED WALKING TO HER OXYGEN TANK BUT DID NOT HAVE THE NASAL CANNULA TUBING TO GO WITH IT AND BEGAN FEELING DELIRIOUS. THE PATIENT CALLED 911 AND WAS REPORTEDLY WITHOUT OXYGEN FOR 20-25 MINUTES. THE PATIENT¿S SPO2 AT THE TIME OF THE EVENT WAS NOT REPORTED. WHEN EMS ARRIVED, THE PATIENT WAS PLACED ON OXYGEN (LITER FLOW NOT REPORTED), AND SHE FELT BETTER. THE PATIENT DECLINED BEING TRANSPORTED TO THE HOSPITAL. IN THIS EVENT, THE PATIENT WAS REPORTEDLY WITHOUT SUPPLEMENTAL OXYGEN FOR APPROXIMATELY 20-25 MINUTES AND BECAME SYMPTOMATIC. IT CAN BE REASONABLY CONCLUDED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION, WHICH WAS LIFE THREATENING AND REQUIRED MEDICAL INTERVENTION (ASSISTANCE FROM EMS, SUPPLEMENTAL OXYGEN) TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, CONCLUDING A SERIOUS INJURY OCCURRED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAIN

    Patient problems: Low Oxygen Saturation

    MAUDE report 20761554 ↗
  • InjuryOct 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE EXPERIENCED OXYGEN DESATURATION WITH USE OF THE LIFE2000 VENTILATOR AND COMPRESSOR, BREATHE PILLOWS INTERFACE, AND INVACARE PLATINUM 10 OXYGEN CONCENTRATOR WITHOUT A BUBBLER. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: Low Oxygen Saturation

    MAUDE report 20580529 ↗
  • InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS SLEEPING WITH THE LIFE2000 VENTILATOR AND WOKE UP SHORT OF BREATH WITH THE DEVICE INTERFACE ON THE FLOOR. THE PATIENT STATED HER OXYGEN SATURATION WAS LOW, HER THROAT WAS SWOLLEN, AND HER LUNG HAD COLLAPSED. THE PATIENT WAS TAKEN TO HOSPITAL, WHERE SHE WAS HOSPITALIZED UNTIL (B)(6) 2024. THE PATIENT NOTED SHE DOES NOT REMEMBER WHAT ALARM THE DEVICE WAS DISPLAYING AS SHE WOKE UP IN A PANIC. THERE WAS NO REPORT OF DEVICE MALFUNCTION. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: Low Oxygen Saturation; Pneumothorax

    MAUDE report 20545339 ↗
  • MalfunctionOct 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE LIFE 200 POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20534624 ↗
  • InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON 8/17/2024, THE PATIENT EXPERIENCED A DESATURATION EPISODE WHILE USING THE LIFE2000 DEVICE DURING THE NIGHT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: Low Oxygen Saturation

    MAUDE report 20200368 ↗
  • MalfunctionJul 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE POWER CORD WAS EXPOSING COPPER WIRES. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19809670 ↗
  • MalfunctionMay 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19393555 ↗
  • MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19288701 ↗
  • MalfunctionApr 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE POWER CORD HAD DAMAGE WITH EXPOSED COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19138303 ↗
  • InjuryFeb 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    A PATIENT REPORTED TO HAVE EXPERIENCED A COPD EXACERBATION AND WAS SUBSEQUENTLY HOSPITALIZED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

    MAUDE report 18811033 ↗
  • MalfunctionFeb 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    BAXTER RECEIVED A REPORT FROM A CUSTOMER STATING THE DEVICE HAD POWER CORD DAMAGE WITH EXPOSED COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18758227 ↗
  • MalfunctionFeb 20, 2024Accessory Incompatible; Accessory Incompatible

    THE CUSTOMER REPORTED THAT THE O2 FLOW METER BALL DROPS WHEN USED WITH THE LIFE2000 DEVICE. THERE WAS NO INJURY REPORTED, MEDICAL INTERVENTION WAS NOT REQUIRED, OR DESATURATION ASSOCIATED WITH THE REPORTED EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18740724 ↗
  • MalfunctionFeb 14, 2024Accessory Incompatible; Accessory Incompatible

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OXYGEN DESATURATION TO 76% SPO2 ON ONE OCCASION WITH THE PATIENT'S USE OF THE LIFE 2000 DEVICE IN CONJUNCTION WITH HER OXYGEN CONCENTRATOR (UNKNOWN MODEL). THE PATIENT DENIES DEVICE ALARMS AND FLOW METER BALL DROP. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT RECOVERED AT HOME BY TURNING OFF THE LIFE 2000 DEVICE AND SWITCHING TO ONLY HER OXYGEN CONCENTRATOR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Patient problems: Low Oxygen Saturation

    MAUDE report 18705941 ↗

Other Continuous, ventilator, home use devices

All Continuous, ventilator, home use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.