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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 MS26800
Device Problem No Audible Alarm (1019)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/29/2023
Event Type  malfunction  
Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.H3 other text : ongoing.
 
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.
 
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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 
9783798000
MDR Report Key18333180
MDR Text Key330578477
Report Number1220063-2023-00050
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098001878
UDI-Public(01)04049098001878(11)231107(93)MS26800-53
Combination Product (y/n)N
PMA/PMN Number
K061379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2023
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 NumberMS26800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2023
Initial Date FDA Received12/15/2023
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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