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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA / DELTA XL; PHYSIOLOGICAL MONITORING SYSTEM
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DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA / DELTA XL; PHYSIOLOGICAL MONITORING SYSTEM Back to Search Results
Model Number MS18284
Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425); Electrical Shorting (2926)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The investigation has been started but has not yet been completed.The investigation outcome will be published in the follow up report.
 
Event Description
It was reported that a short circuit occurred in the power supply which resulted in a flame that melted the housing and caused a strong unpleasant smell.There was no report of patient involvement or patient injury.
 
Manufacturer Narrative
The failed power supply was returned to draeger where the melted housing and internal pcb damage was confirmed.Further inspection showed that the internal pcb damage was contained within the power supply housing and excessive heat was the cause of the hole in the casing.There was no indication that the flame escaped from the power supply housing.The power supply was sent to the supplier who identified root cause as a broken solder connection.However, what caused the breakage could not be determined.A query of the complaint data base for similar reports shows this as an isolated case.The device is designed to meet the iec 60601-1 standard for basic safety and essential performance of medical electrical equipment and the risk of fire is minimized because the used materials are classified ul 94 v-0 or better.
 
Event Description
It was reported that a short circuit occurred in the power supply which resulted in a flame that melted the housing and caused a strong unpleasant smell.There was no report of patient involvement or patient injury.
 
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Brand Name
INFINITY DELTA / DELTA XL
Type of Device
PHYSIOLOGICAL MONITORING SYSTEM
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS, INC
6 tech drive
andover MA 01810 2434
Manufacturer Contact
dhaval trivedi
6 tech drive
andover, MA 01810-2434
MDR Report Key7029722
MDR Text Key92051687
Report Number1220063-2017-00059
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K152407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2000
Device Model NumberMS18284
Device Catalogue NumberMS18284
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
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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