Device product

Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP

Z-0886-2025

December 20, 2024

Class I

Product summary

Firm: Baxter Healthcare Corporation
Event: Event 95842
Status: Ongoing
Classification: Class I
Quantity: 1 unit
Official record key: device-enforcement:Z-0886-2025

Official wording

Reason: 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.

Code information: UDI/DI 00887761981638, Serial Numbers: 122010001081

Distribution pattern: US, Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.