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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 Date 02/07/2024
Event Type  malfunction  
Event Description
It was reported that the jm-105 provided low values.No adverse patient impact was reported.
 
Manufacturer Narrative
The investigation was started; results will be provided in a follow up-report.
 
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Brand Name
JAUNDICE JM105
Type of Device
JAUNDICE METER/BILIRUBINOMETER
Manufacturer (Section D)
DRAEGER MEDICAL SYSTEMS INC
6 tech drive
andover MA
Manufacturer (Section G)
DRAEGER MEDICAL SYSTEMS, INC
3135 quarry road
telford PA
Manufacturer Contact
3135 quarry road
telford, PA 
9784828529
MDR Report Key18777815
MDR Text Key337311392
Report Number2510954-2024-00004
Device Sequence Number1
Product Code MQM
Combination Product (y/n)N
PMA/PMN Number
K133175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
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 01/11/2024
Initial Date FDA Received02/26/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/13/2023
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 Age4 DA
Patient RaceWhite
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