Draeger Medical Systems, Inc.: The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

Agency Publication Date: April 27, 2023

Affected Products

Product: Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower

Product: Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,

UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91938

Status: Active

Manufacturer: Draeger Medical Systems, Inc.

Manufactured In: United States

Units Affected: 2 products (6803 systems; 19,429 systems)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower

UDI-DI: 04049098048989 (M300), 04049098095778 (M300+); All Systems Running Software versions: VG2.4 and lower