Recall Z-0263-2012 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Draeger Medical, Inc.
Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.
| Date | Nov 22, 2011 (initiated Oct 18, 2011) |
| Status | Terminated |
| Reason | During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition, a misalignment of ECG and ART waveforms delivered from an Infinity(RO Acute Care System (IACS) Monitoring Solution (M540) was observed on the Infinity Central Station. |
| Root cause | Software design |
| Action | The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed o |
| Quantity | 476 |
| Distribution | Nationwide distribution - IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION Draeger Medical Systems, Inc., Mar 8, 2010 |