MAUDE Adverse Event Report: MEDIANA CO. LTD. NELLCOR; OXIMETER

Model Number	N65
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the unit had partially missing segments.The customer reported that there was no patient involvement.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• MDR Report Key: 7440396
• Report Number: 2936999-2018-00270
• Device Sequence Number: 11118242
• Product Code: DQA
• UDI-Device Identifier: 10884521096752
• UDI-Public: 10884521096752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N65
• Device Catalogue Number: N65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1