FDA Recall: Software Issue May Cause Battery Malfunction

Company: Philips Respironics, Inc.
Date of Enforcement Report: March 19, 2024
Class I

PRODUCT

Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal

Recall Number:

Z-1502-2024

REASON:

Philips Respironics, Inc. has notified customers to update to the latest software version (1.05.06.00) of its Trilogy Evo continuous ventilator devices due to a possible power malfunction. Due to a software issue, these ventilators can issue a “Battery Depleted” or “Loss of Power” alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms. All Trilogy Evo ventilators (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300) are susceptible to this problem, except those ventilators with the software version 1.05.06.00 installed.

The software algorithm that calculates remaining battery life can malfunction and cause the ventilator to either:

  • Issue a “Loss of Power” alarm that stops assisted breathing support therapy while operating on battery power alone.
  • Issue a “Battery Depleted” alarm while continuing therapy if plugged into a permanent power source, such as AC or DC power.

This situation occurs only when all of the following conditions are met:

  • Software other than version 1.05.06.00 is installed on the ventilator,
  • The ventilator is operating in CPAP or PSV mode, and
  • The ventilator is not able to detect the respiratory effort of the patient for at least 10 minutes and 45 seconds.

The use of the affected ventilators may result in ventilator power down and no delivery of therapy to the patient, even though the battery is not depleted. This could cause serious adverse health consequences, including hypoventilation and death.

As of May 13, 2024, there are no reports of death or serious injury related to this issue in the Manufacturer and User Facility Device Experience (MAUDE) database, which contains medical device reports (MDRs) of adverse events.

RECALLING FIRM/MANUFACTURER:

Philips Respironics, Inc

VOLUME OF PRODUCT IN COMMERCE:

90,905

DISTRIBUTION:

AE, AR, AT, AU, BD, BE, BG, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PR, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, UA, US, UY, VN, YT, ZA, ZW

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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