• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRAEGER MEDICAL SYSTEMS, INC JM-105 JAUNDICE METER; JAUNDICE METER/BILIRUBINOMETER Back to Search Results
Model Number MU20105
Device Problem Low Readings (2460)
Patient Problem Jaundice (2187)
Event Date 06/23/2023
Event Type  malfunction  
Event Description
It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.
 
Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
 
Event Description
It was reported that the draeger jm105 jaundice meter was providing inconsistent/low readings.No adverse patient impact was reported.
 
Manufacturer Narrative
A complaint was received involving inconsistent readings between the jm-105 transcutaneous bilirubin (tcb) and total serum bilirubin (tsb) blood test results.No adverse patient impact was reported.It was confirmed that the device was being used correctly.Data, collected by the customer, was provided to the product manager and marketing manager/ registered respiratory therapist (rrt) for review.Based on the rrt's evaluation of the data, it was recommended that the device be returned to draeger for calibration and training be reviewed with the customer.The customer declined retraining but agreed to send the device back to draeger for recalibration.Upon return of the device, the service technician found that the device would not stay in service mode.Troubleshooting identified a faulty pcb and once replaced, the device was recalibrated successfully.No further issues have been reported.H3 other text : see h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
JM-105 JAUNDICE METER
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 
2156602400
MDR Report Key17367686
MDR Text Key319766759
Report Number2510954-2023-00013
Device Sequence Number1
Product Code MQM
UDI-Device Identifier04049098000246
UDI-Public(01)04049098000246(11)230210(93)MU20105-24
Combination Product (y/n)N
PMA/PMN Number
K133175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/24/2024
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 Model NumberMU20105
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/23/2023
Initial Date FDA Received07/20/2023
Supplement Dates Manufacturer Received01/03/2024
Supplement Dates FDA Received04/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-