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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 01/19/2024
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
A followup report will be submitted upon completion of this investigation.
 
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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 
2156602400
MDR Report Key18604341
MDR Text Key335087451
Report Number1220063-2024-00012
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04049098001878
UDI-Public(01)04049098001878(11)140226(93)MS26800-09
Combination Product (y/n)N
PMA/PMN Number
K061379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 01/29/2024
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 NumberMS26800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/19/2024
Initial Date FDA Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NA.
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