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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA XL; PHYSIOLOGIC MONITORING SYSTEM

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DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA XL; PHYSIOLOGIC MONITORING SYSTEM Back to Search Results
Catalog Number MS13466
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Tachycardia (2095)
Event Date 12/20/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
It was reported that the user witnessed a patient with a high heart rate, but the patient monitor did not appear to be visually showing the patients symptoms.There was no report of an adverse event or patient injury.
 
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Brand Name
INFINITY 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 Key18720781
MDR Text Key336638680
Report Number1220063-2024-00021
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K152407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/16/2024
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 NumberMS13466
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2024
Initial Date FDA Received02/16/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2005
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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