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

Catalog Number MK31701

Device Problems Insufficient Information (3190); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

A followup report will be submitted upon completion of this investigation.

Event Description

It was reported that the iacs became unresponsive during cardioversion.No adverse patient impact was reported however, this could indicate a delay in treatment occurred.

Event Description

It was reported that the iacs became unresponsive during cardioversion.No adverse patient impact was reported however, this could indicate a delay in treatment occurred.

Manufacturer Narrative

Initially it was reported that the iacs became unresponsive during cardioversion.This case was reported as it was unclear if the m540 was unresponsive.Later it was clarified that only the c700/cockpit became unresponsive.An unresponsive c700/cockpit display is visibly obvious to the user.The associated independent m540 bedside monitor is not impacted and will continue to monitor the patient and provide alarms at limits set.Investigation results: the workflow around the cardioversion performed and type of cardioversion (electrical [internal/external] and pharmacological) were requested but not provided.The log files were reviewed and confirmed the reported symptom, but a precise root cause could not be identified.Draeger engineering ran various simulations and were unable to reproduce any of the anomalies from the event.It was determined that the site was using older cables and an m500 with hardware revision 11, while the latest revision of the hardware is revision 21.As a result, it is recommended for the site to use updated hardware with the latest software release for best performance of the system.The cited c700 was replaced and tested with no malfunctions identified.No further issues have been reported.H3 other text : the cited c700 was replaced and tested with no malfunctions identified.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer h3 other text : the cited c700 was replaced and tested with no malfunctions identified.

Event Description

It was reported that the iacs became unresponsive during cardioversion.No adverse patient impact was reported however, this could indicate a delay in treatment occurred.

• 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
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 12305027
• MDR Text Key: 267524368
• Report Number: 1220063-2021-00022
• 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): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

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 Catalogue Number: MK31701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 07/15/2021; 07/15/2021
• Supplement Dates FDA Received: 02/04/2022; 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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): Required Intervention