MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540)

Device Problem Defective Alarm (1014)

Patient Problems Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

Logs were received, however the date of event was overwritten as the device remained in use during this time.Additional information was requested, however was not available where the event was from 4 months ago.Draeger tested the device and no problems were found.The device passed all testing.No device malfunction could be verified and therefore root cause could not be determined.This is an isolated case.

Event Description

Draeger received a complaint in october 2019 for an event that occurred in (b)(6) 2019.It was reported a patient told one of the nurses that he was having a strange feeling, the nurse looked at the monitor and found out that patient was on vt at 200 heart beats, she called for help, doctor went, and when i arrived doctor and the nurse were presented, patient wasn't responding, looking straight, not responsive, monitor wasn't alarming or beeping, despite patient was on vt at 200 but not sound or any alarm was made.Rhythm has self-resolved, attached patient on defibrillator.There was no reported adverse patient impact.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA 01810 2434
• MDR Report Key: 9316918
• MDR Text Key: 205498230
• Report Number: 1220063-2019-00023
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/13/2019
• 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