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

Catalog Number MS25510

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problem Death (1802)

Event Date 01/06/2021

Event Type  Death  

Manufacturer Narrative

After review of the m540 logs, it was found that alarms generated for spo2 sensor off and ecg leads off at 0:24:15 and 0:26:41 respectively.It was found that the spo2 sensor was reattached at 1:01:18 and the ecg leads were reattached at 1:01:28.It was found that alarms started generating for asystole and spo2 desaturation after the spo2 sensor and ecg leads were reattached.After review of the ics logs, it was found the first time any alarm was acknowledged from the cited bedside for the event was on 1:09:30.Additional information was provided from the customer confirming that there was no allegation of any draeger device malfunction and noting that during the night shift there is no one appointed to the ics full time, no one was there during the time of the event.Note that the ics instructions for use provides the following warning: the user must remain within the hearing range of the acoustic alarm signal.This operator position makes it possible to quickly detect an alarm and to respond accordingly.The distance to the medical device must be appropriate for the volume of the alarm signal.This information was forwarded to the customer.There was no draeger device malfunction/draeger devices can be excluded as a factor in the patient outcome.

Event Description

It was reported that a patient in an isolation room got leads disconnected and the alarms might not have been acknowledged at the central station.Patient unfortunately died after complications.

• 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
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 11279352
• MDR Text Key: 230279898
• Report Number: 1220063-2021-00001
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/03/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS25510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death