Recall Z-1472-2023 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical Systems, Inc.
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,
| Date | Apr 27, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | An Urgent - Medical Device Correction notification letter dated March 2023 was sent to customers. Actions to be taken: Until the corrected software is available and installed, clinicians should utilize the Draeger ICS/MSOO Instructions For Use while applying any additional means of standard practices for assessment of patients with unusually high and/or low QRS amplitudes. Clinicians should combine this information with physical assessment of the patient and follow standard clinical practice. Please ensure that all users of the affected products listed above and other people within your orga |
| Quantity | 19,429 systems |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200859 | Infinity M300 Draeger Medical Systems, Inc., Aug 28, 2020 |