• 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 JAUNDICE JM105; 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 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.H3 other text : device evaluated by manufacturer, investigation ongoing.
 
Event Description
The customer reported that a jaundice meter had multiple low readings when compared to the tsb.Additional information regarding the low readings, patient age and conditions was requested.No patient injury or death was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key19203890
MDR Text Key341301403
Report Number2510954-2024-00007
Device Sequence Number1
Product Code MQM
UDI-Device Identifier04049098000246
UDI-Public(01)04049098000246(11)230505(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 Health Professional,User Facility
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2024
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? Yes
Date Device Manufactured05/05/2023
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;
-
-