Life2000Recalls & reported problems across all models

We found 4 models of Life2000 by Welch Allyn, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Nov 1, 2023 and Oct 24, 2024 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 reports).

11 FDA recall records name at least one of these models by its device identifier, 11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Life2000 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 7, 2025Open, Classified

   A cybersecurity vulnerability was discovered through internal testing.

   Z-1726-2025 · Root cause: Software in the Use Environment · names 3 of these models · Recall details · FDA record ↗

2. Apr 7, 2025Open, Classified

   A cybersecurity vulnerability was discovered through internal testing.

   Z-1725-2025 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

3. 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-0887-2025 · Root cause: Process control · Recall details · FDA record ↗

4. 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-0886-2025 · Root cause: Process control · Recall details · FDA record ↗

5. 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-0885-2025 · Root cause: Process control · Recall details · FDA record ↗

6. Sep 12, 2024Open, Classified

   The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.

   Z-0046-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

7. May 29, 2024Open, Classified

   Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the ventilator's internal battery from charging.

   Z-2140-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jan 25, 2023Open, Classified

   There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

   Z-1142-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Jan 25, 2023Open, Classified

   There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

   Z-1141-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Jan 25, 2023Open, Classified

    There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

    Z-1140-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Jan 25, 2023Open, Classified

    There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

    Z-1139-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Life2000 problems

Life2000 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Life2000 MS-01-0118

  Continuous, ventilator, home use
  10 recalls2 reports
• Life2000 MS-01-0093

  Compressor, air, portable
  1 recall1 death5 reports
• Life2000 MS-01-0125

  Compressor, air, portable
  1 recall0 reports
• Life2000 MS-01-0121

  Compressor, air, portable
  1 recall0 reports

Recent Life2000 adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2024Electrical Power Problem; Electrical Power Problem

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE POWER CORD WAS BURNT. 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 20527550 ↗
• DeathJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 5/21/24, THE PATIENT'S GRANDDAUGHTER REPORTED THAT AFTER THE DEVICE WAS BLOWING HOT AIR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19571247 ↗
• MalfunctionDec 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE DEVICE HAD POWER CORD 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 18329603 ↗
• MalfunctionDec 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN STATING THE DEVICE HAD POWER CORD 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 18302672 ↗
• InjuryDec 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT ASSOCIATES HER DIAGNOSIS OF PNEUMONIA TO THE USE OF THE LIFE 2000 DEVICE NASAL INTERFACE TUBING. THE PATIENT REPORTED THAT SHE FEELS LIKE SHE IS CHOKING WHEN SHE WEARS THE INTERFACE TUBING AT NIGHT, AND THAT THERE IS WATER COMING THROUGH THE HOSE AND OUT THROUGH THE NASAL PILLOWS. THERE WAS NO REPORT OF OXYGEN DESATURATION OR CHANGES IN FLOW METER ASSOCIATED WITH THE PATIENT¿S THIRD-PARTY OXYGEN CONCENTRATOR. THE PATIENT REPORTED THAT SHE STARTED COUGHING, COULDN¿T STOP, AND THEREFORE WENT TO THE HOSPITAL AND WAS ADMITTED WITH A DIAGNOSIS OF PNEUMONIA. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Pneumonia

  MAUDE report 18291520 ↗
• MalfunctionNov 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE POWER CORD WAS DAMAGED 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 18239689 ↗
• MalfunctionNov 1, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  BAXTER RECEIVED A REPORT STATING THE DEVICE POWER CORD WAS BURNT. 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 18049290 ↗

Other Welch Allyn, Inc. products

• Welch Allyn Connex6 models · 0 reports · 2 recalls