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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGIC MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGIC MONITORING SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Tachycardia (2095)
Event Date 03/27/2024
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
The customer reported that the ics did not give an alarm for a ventricular tachycardia event (red alarm), and that the device give a yellow alarm for another ventricular tachycardia event in an icu.There was no report of patient injury or death.
 
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Brand Name
INFINITY CENTRAL STATION
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 Key19067108
MDR Text Key339674919
Report Number1220063-2024-00040
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K061379
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 04/08/2024
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 NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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