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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC JAUNDICE JM105; JAUNDICE METER/BILIRUBINOMETER

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DRAEGER MEDICAL SYSTEMS, INC JAUNDICE JM105; JAUNDICE METER/BILIRUBINOMETER Back to Search Results
Catalog Number MU20105
Device Problem Low Readings (2460)
Patient Problem Jaundice (2187)
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 jm 105 had low readings when compared to tsb readings throughout the month of march.No patient injury or death was reported.
 
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Brand Name
JAUNDICE JM105
Type of Device
JAUNDICE METER/BILIRUBINOMETER
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 Key19203808
MDR Text Key341295036
Report Number2510954-2024-00008
Device Sequence Number1
Product Code MQM
UDI-Device Identifier04049098000246
UDI-Public(01)04049098000246(11)231212(93)MU20105-25
Combination Product (y/n)N
PMA/PMN Number
K133175
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/29/2024
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 NumberMU20105
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2023
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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