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

Model Number MS20401

Device Problem Low Readings (2460)

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

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The user reports very high deviations in the measured values between invasive arterial blood pressure measurement and non-invasive blood pressure measurement.(diastolic > 25mmhg difference).No adverse patient impact was reported.The infinity acute care system (iacs) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.

Event Description

The user reports very high deviations in the measured values between invasive arterial blood pressure measurement and non-invasive blood pressure measurement.(diastolic > 25mmhg difference).No adverse patient impact was reported.The infinity acute care system (iacs, sw version vg7.1.1) includes an infinity medical cockpit paired with an infinity m540 bedside monitor.

Manufacturer Narrative

The following was noted by the customer.The problem does not occur on a specific device, accessory or location.The issue is intermittent and occurs on a wide variety of patients of different ages and symptoms.All measures for correct measurement were adhered.We have been working with the system for many years and never had such deviations with so many different patients.In january 2021, a wide range of c500 and c700 were upgraded to the new generation (3rd generation) including new software vg7.1.1 a draeger service technician evaluated the involved hardware using multiple m540 devices (dual and quad hemo pods, dual hemo mcables, nibp cuffs, transducer) with no malfunctions identified.It was confirmed that the draeger devices were maintained and calibrated regularly (within the required timelines).Draeger personnel went onsite to accompany a few surgeries but was not able to observe any abnormalities and the error did not occur.The customer stated the problem still occurs in some cases with different m540/dual hemo pods.As the reported issue cannot be reproduced and no device malfunctions have been identified, root cause cannot be determined.An additional onsite visit is scheduled in april to review clinical workflow and perform further device accessory verification as needed.If more information is obtained from this visit, an updated report will be submitted.H3 other text : see h10.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEM
• 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: 16084039
• MDR Text Key: 307312505
• Report Number: 1220063-2023-00001
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098054454
• UDI-Public: 04049098054454
• Combination Product (y/n): N
• PMA/PMN Number: K203088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Model Number: MS20401
• Device Catalogue Number: MS20401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/02/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2013
• 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