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

Model Number JM105

Device Problems False Reading From Device Non-Compliance (1228); Nonstandard Device (1420)

Patient Problems Neuropathy (1983); Jaundice (2187)

Event Date 10/20/2017

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 (phototherapy, and double exchange transfusion).Draeger has initiated a field action.

Event Description

Due to a processing error, this mdr is being submitted late.The customer reported that a patient suspected of being jaundiced was screened with the meter which displayed a blinking -0- and the patient was discharged due to the user misinterpreting the out of range bilirubin reading ("-o-") the jaundice meter displayed.There was a delay in treatment (phototherapy, and double exchange transfusion).It was reported the patient has been diagnosed with bilateral auditory neuropathy.

• 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: 7473939
• MDR Text Key: 106954052
• Report Number: 2510954-2018-00003
• Device Sequence Number: 1
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/23/2018

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: 12/13/2017
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2015
• 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