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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS
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DRAEGER MEDICAL SYSTEMS, INC INFINITY CENTRAL STATION; PHYSIOLOGICAL MONITORING SYSTEMS Back to Search Results
Catalog Number MS32504
Device Problem No Audible Alarm (1019)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/27/2023
Event Type  malfunction  
Event Description
It was reported that the users became aware that the external loudspeakers for the infinity central monitoring station will stay inactive after return of electrical power following an outage or disconnection.There was no patient involvement reported for the particular case.
 
Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.H3 other text : on-going.
 
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Brand Name
INFINITY CENTRAL STATION
Type of Device
PHYSIOLOGICAL MONITORING SYSTEMS
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 
9784470587
MDR Report Key18129229
MDR Text Key327998401
Report Number9611500-2023-00409
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/14/2023
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 NumberMS32504
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2023
Initial Date FDA Received11/14/2023
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
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