MAUDE Adverse Event Report: DRAEGER, INC. DRAEGER JAUNDICE METER JM-105; JM-105 JAUNDICE METER

Model Number JM-105

Device Problem Display Difficult to Read (1181)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2016

Event Type  Injury  

Event Description

"critical" transcutaneous billrubin level on this device (greater than 340 umol/l or greater than 20 mg/dl) registers as flashing "- 0 -" with units displayed below (either mg/dl or umol/l).On more than one occasion nurses have taken this to literally mean "0" and have not acted appropriately (which is to either draw a serum bilirubin or at least notify the physician).This has occurred in spite of fairly intensive nursing training in device use.To avoid misinterpretation it is suggested that software be modified so that critical values are displayed as "hi", "- ! -" or similar.

• Brand Name: DRAEGER JAUNDICE METER JM-105
• Type of Device: JM-105 JAUNDICE METER
• Manufacturer (Section D): DRAEGER, INC.; 3135 quarry rd.; telford PA 18969
• MDR Report Key: 5952373
• MDR Text Key: 54935724
• Report Number: MW5064767
• Device Sequence Number: 1
• Product Code: MQM
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JM-105
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention