MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. JAUNDICE METER; NON-INVASIVE TRANSCUTANEOUS BILIRUBMINOMETER

Model Number JM105

Device Problem No Display/Image (1183)

Patient Problem No Code Available (3191)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

There is no indication that the meter did not function as intended.The users in this case misinterpreted the displayed "-o-" display for an out of range bilirubin reading.As a result there was a delay in treatment for the patient.An mri has revealed that there are 2 small brain lesions, which may be possibly attributed to jaundice.Draeger has initiated a field action.

Event Description

Due to the unclear display, an increased bilirubin value was not detected.The treatment of the patient was therefore not initiated on time.

• Brand Name: JAUNDICE METER
• Type of Device: NON-INVASIVE TRANSCUTANEOUS BILIRUBMINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• Manufacturer Contact: dhaval trivedi ; 3135 quarry road; telford, PA 18969 ; 9783798077
• MDR Report Key: 7503544
• MDR Text Key: 107899071
• Report Number: 2510954-2018-00004
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Model Number: JM105
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1220063-04/17/2018-001-C
• Patient Sequence Number: 1
• Patient Outcome(s): Disability