Rhythm Healthcare P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06971882890017), received between Jun 8, 2026 and Jun 8, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Alarm” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Defective Alarm; Gas/Air Leak; Undercorrection

  TECHNICAL AUDIT OF RHYTHM P2 POC PLATFORM CONFIRMS A SYSTEMIC 'SILENT FAILURE' MODE WHERE DEVICES DELIVER SUB-THERAPEUTIC OXYGEN (DOCUMENTED AS LOW AS 42% O2) WITHOUT TRIGGERING MANDATORY SAFETY ALARMS.FORENSIC TESTING IDENTIFIED AN 'OSCILLATION LOOPHOLE' IN THE ALARM LOGIC: THE DEVICE REQUIRES 600S OF CONTINUOUS LOW O2 TO ALARM, BUT ERRATIC INTERNAL SENSOR READINGS (FLUCTUATING 40%-90%) RESET THE TIMER, PREVENTING ISO 80601-2-69 ALERTS.NIST-TRACEABLE TESTING CONFIRMS A 10-30% POSITIVE BIAS IN ONBOARD DIAGNOSTICS. MANUFACTURER'S (B)(6) 2023 FORWARD ONLY FIRMWARE FIX IS DOCUMENTED AS INEFFECTIVE IN 2024 PRODUCTION UNITS.THIS DEFECT PRESENTS A RISK OF SERIOUS INJURY OR DEATH TO OXYGEN-DEPENDENT PATIENTS DUE TO LOSS OF DETECTABILITY OF HAZARDOUS CONDITIONS.P2#1 (SN# (B)(6)) ONBOARD READING: VARIABLE (52-71%); ANALYZER READING: 47.9%; NO LOW O2 WARNING! P2#2 (SN# (B)(6)) ONBOARD READING: VARIABLE (62-91%); ANALYZER READING: 60%; NO LOW O2 WARNING! P2#3 (SN# (B)(6)) ONBOARD READING: VARIABLE (66-91%); ANALYZER READING: 78.8%; LOW O2 WARNING P2#4 (SN# (B)(6)) ONBOARD READING: VARIABLE (83-91%); ANALYZER READING: 74.2%; NO LOW O2 WARNING! P2#5 (SN# (B)(6)) ONBOARD READING: VARIABLE (75-92

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438418 ↗