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

Model Number	JM105
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The jm105 jaundice meter s/n (b)(4) & base assembly s/n (b)(4) were received in good physical condition.The meter was tested on the base checker & the long optical path read -1.5, the short optical path read -0.9 & the delta value read -0.6.Meter performed as intended.
Event or Problem Description
The meter jm-105 showed flashing -0- which was interpreted by the user as a bilirubin value of 0.The patient was sent home without a follow-up serum blood test for bilirubin & returned to the hospital after 2 days with a bilirubin value of over 600 mmol.

• Brand Name: JAUDICE METER
• Common Device Name: NON-INVASIVE TRANSCUTANEOUS BILIRUBINOMETER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 6376480
• Report Number: 2510954-2017-00001
• Device Sequence Number: 16306188
• Product Code: CBK
• UDI-Device Identifier: 04049098000246
• UDI-Public: (01)04049098000246(11)160411(17)180407(93)MU20105-11
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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
• Operator of Device: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1