Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGICAL MONITORING SYSTEMS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results
Catalog Number MK31501
Device Problem Device Sensing Problem (2917)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/20/2023
Event Type  malfunction  
Event Description
It was reported that during an ongoing cpr the patient monitoring system failed to provide eco2 data which made clinical decisions in this situation more challenging.It was confirmed the resuscitation was successful that the patient was transferred to the icu.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.
 
Manufacturer Narrative
T was reported the etco2 was functioning when undocked but once the m540 is docked, the etco2 reading disappears.A spare m540 was installed which replicated the reported issue then a spare m500 was installed.Once the m500 was put into place, the m540 was able to be docked while still displaying the etco2 readings.Upon draeger's receipt of the iacs, the system was evaluated where it was confirmed the cause of the issue was due to a faulty daughterboard.The daughterboard (pcb m500 daughter brd v7) was replaced in the m500 then sent back to the customer for use.
 
Event Description
It was reported that during an ongoing cpr the patient monitoring system failed to provide eco2 data which made clinical decisions in this situation more challenging.It was confirmed the resuscitation was successful that the patient was transferred to the icu.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFINITY ACUTE CARE SYSTEM (M540)
Type of Device
PHYSIOLOGICAL MONITORING SYSTEMS
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
GM 
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
Manufacturer Contact
3135 quarry road
telford, PA 
9783798000
MDR Report Key17884010
MDR Text Key325072311
Report Number1220063-2023-00035
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098009751
UDI-Public04049098009751
Combination Product (y/n)N
PMA/PMN Number
K113798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/01/2024
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 Catalogue NumberMK31501
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/20/2023
Initial Date FDA Received10/06/2023
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received05/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.
-
-