Life2000 MS-01-0093Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00887761978072), received between Nov 1, 2023 and Oct 24, 2024 — classified as 1 death, 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 7, 2025Class IOpen, Classified

   A cybersecurity vulnerability was discovered through internal testing.

   Z-1726-2025 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, 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 ↗
• 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 ↗