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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAEGER MEDICAL INFANT CARE, INC. JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER

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DRAEGER MEDICAL INFANT CARE, INC. JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER Back to Search Results
Model Number MU26222
Device Problem Low Readings (2460)
Patient Problem Jaundice (2187)
Event Date 03/30/2023
Event Type  malfunction  
Manufacturer Narrative
Draeger contacted the customer who stated the device was repaired by a 3rd party, the sensor had failed.H3: see h10.
 
Event Description
At 9:15am on 30 march 2023, the device passed the pre use check.During use, the user found the measured value was abnormal, changed to other device to measure again.The user stopped use the device and reported it to the biomedical technician.No adverse patient impact was reported.
 
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Brand Name
JM-105 JAUNDICE METER
Type of Device
JAUNDICE METER/BILIRUBINOMETER
Manufacturer (Section D)
DRAEGER MEDICAL INFANT CARE, 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 
MDR Report Key16872993
MDR Text Key314657655
Report Number2510954-2023-00004
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2023
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 Model NumberMU26222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received05/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2021
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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