FDA-Device2023-05-03Class II
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,
Draeger Medical Systems, Inc.
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
19,429 systems
Manufactured in
6 Tech Dr, N/A, Andover, MA, United States
Products
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,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1472-2023Don't want to check this manually?
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