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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC DELTA XL; PHYSIOLOGIC MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC DELTA XL; PHYSIOLOGIC MONITORING SYSTEM Back to Search Results
Catalog Number MS18596
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2024
Event Type  malfunction  
Event Description
The customer reported that the patients carbon dioxide values and waveforms could not be displayed on the delta during operation, and that the anesthesiologist could not judge the patient's condition.There was no report of patient injury or death.
 
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Manufacturer Narrative
A complaint was submitted where it was reported that the patient's carbon dioxide values and curves were not displayed on the delta xl monitor during a surgical procedure.The cause of the reported issue was reportedly due to a faulty carbon dioxide module.Several attempts were made to obtain additional information; however, no further information has been provided.It is not known what was wrong with module or what actions were performed due to the inability of the customer to provide the necessary information needed to determine a precise root cause.This complaint is being closed and if in the future, relevant information is provided a new complaint will be opened.There was no report of adverse event or patient injury.
 
Event Description
The customer reported that the patients carbon dioxide values and waveforms could not be displayed on the delta during operation, and that the anesthesiologist could not judge the patient's condition.There was no report of patient injury or death.
 
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Brand Name
DELTA XL
Type of Device
PHYSIOLOGIC MONITORING SYSTEM
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 
9784828529
MDR Report Key19153114
MDR Text Key340804562
Report Number1220063-2024-00047
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098004169
UDI-Public(01)04049098004169(11)190405(93)MS18596-65
Combination Product (y/n)N
PMA/PMN Number
K152407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMS18596
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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