Life2000 MS-01-0118Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887761978089), received between Dec 11, 2023 and Dec 14, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

10 FDA recall records name this device's identifier, 10 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.

Recalls naming this device

1. Apr 7, 2025Open, Classified

   A cybersecurity vulnerability was discovered through internal testing.

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

2. 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 · 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-0885-2025 · Root cause: Process control · 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 · FDA record ↗

5. 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 · FDA record ↗

6. 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 · FDA record ↗

7. 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 · 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-1141-2023 · Root cause: Under Investigation by firm · 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-1140-2023 · Root cause: Under Investigation by firm · 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-1139-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗