MAUDE Adverse Event Report: DRAEGER MEDICAL INC JM103 TRANSCUTANEOUS BILIMETER; JAUNDICE METER JM-103

Model Number JM 103

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Code Available (3191)

Event Date 07/17/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, mom delivered a normal ((b)(6)) newborn preterm at (b)(6) gestation.On (b)(6) 2014, nurse was performing routine order for a 24 hour (tcb) transcutaneous bilirubin using the transcutaneous bilirubinometer (jaundice meter) on newborn (b)(6) age.The initial reading on the jaundice meter screen was (- - -) lines across the screen.The nurse then attempted to recalibrate and tried several times on newborn to obtain a numerical reading and was unsuccessful.Nurse did attempt to perform tcb on herself and was able to get a numerical reading and therefore thought there was a problem with the meter.Nurse then obtained a serum bilirubin and level was 25.1 mg/dl.Baby required emergency exchange transfusion and transfer to nicu.

• Brand Name: JM103 TRANSCUTANEOUS BILIMETER
• Type of Device: JAUNDICE METER JM-103
• Manufacturer (Section D): DRAEGER MEDICAL INC; telford PA 18969
• MDR Report Key: 4148885
• MDR Text Key: 4909899
• Report Number: MW5038489
• Device Sequence Number: 1
• Product Code: MQM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/01/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: JM 103
• Device Catalogue Number: OB-392
• Other Device ID Number: NI-MH 2.4V
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 1 DA
• Patient Weight: 3