• 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
Device Problem Low Readings (2460)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/24/2023
Event Type  malfunction  
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 reading lower than blood serum.No patient injury was reported.
 
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 
MDR Report Key17577206
MDR Text Key321636123
Report Number2510954-2023-00015
Device Sequence Number1
Product Code MQM
UDI-Device Identifier04049098000246
UDI-Public(01)04049098000246(11)221121(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
Report Date 08/18/2023
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2023
Initial Date FDA Received08/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NA.
-
-