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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
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DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT Back to Search Results
Catalog Number MS20401
Device Problem No Visual Prompts/Feedback (4021)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
 
Event Description
The customer reported that the draeger m540 was not reading a patient's temperature and was not providing ekg readings.The m540 was swapped out.There was approximately 30 seconds in delay to patient treatment.There was no report of adverse event or patient harm.
 
Manufacturer Narrative
It was reported the m540 was not reading patient temperature.A draeger fse (field service engineer) went onsite to evaluate the m540 unit but was unable to verify/duplicate the reported issue.As the temperature cables were discarded prior to evaluation, a precise root cause could not be determined however, the reported issue is consistent with faulty temperature cables.The fse performed device checks iaw draeger ipm-l service procedures then was able to verify proper temperature readings were displaying on the m540.It was confirmed all tests passed draeger specifications then the unit was returned to service.
 
Event Description
The customer reported that the draeger m540 was not reading a patient's temperature and was not providing ekg readings.The m540 was swapped out.There was approximately 30 seconds in delay to patient treatment.There was no report of adverse event or patient harm.
 
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Brand Name
INFINITY ACUTE CARE SYSTEM (M540)
Type of Device
PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
Manufacturer Contact
3135 quarry road
telford, PA 
2156602400
MDR Report Key18757203
MDR Text Key335989768
Report Number1220063-2024-00020
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098054454
UDI-Public(01)04049098054454(11)191119(93)MS26372-53
Combination Product (y/n)N
PMA/PMN Number
K113798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/26/2024
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 NumberMS20401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2024
Initial Date FDA Received02/22/2024
Supplement Dates Manufacturer Received03/22/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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