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

Model Number	N65-1
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/14/2019
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 an inaccurate reading.The customer reported that the reading is lower than normal.It was i ndicated that there was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.Functional test was performed, and all test passed, no failure mode was observed.The investigation found the device to function normally.No new formal investigation is required, the event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.

• 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: 8390975
• Report Number: 2936999-2019-00162
• Device Sequence Number: 16575173
• Product Code: DQA
• UDI-Device Identifier: 10884521096738
• UDI-Public: 10884521096738
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K051352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: N65-1
• Device Catalogue Number: N65-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1