MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problems Cyanosis (1798); Respiratory Failure (2484)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

A complaint was received regarding an m540 patient monitor where the patient had stopped breathing during 3 minutes with no alarm and the staff noticed only when the patient was blue.The customer noted that they thought there were small alarms at the central.

Manufacturer Narrative

The patient was stabilized by sternal rub and application of oxygen mask at 10l.Spo2 climbed from 6% and recovered to >92% within seconds.Additional information was provided clarifying that yellow alarms were generated for low spo2 at both the bedside and central station during the event but that a red alarm was expected by the staff.Review of the log files confirmed the yellow spo2 alarms were provided during the event, the device was being used in adult mode and the iacs software was vg4.1.The instructions for use states that the red spo2 desaturation alarm is only available in neonatal mode.There was no device malfunction.This is an isolated case.Note that this was initially reported based on no alarm being provided for low spo2.However, this investigation confirmed alarms were provided as designed and there was no device malfunction.Therefore, this would not be likely to cause or contribute to a death or serious injury if it were to recur.

Event Description

A complaint was received regarding an m540 patient monitor where the patient had stopped breathing during 3 minutes with no alarm and the staff noticed only when the patient was blue.The customer noted that they thought there were small alarms at the central.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 8861936
• MDR Text Key: 153363541
• Report Number: 1220063-2019-00015
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K093788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1