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

Model Number	N560
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 device does not mark the digits well.There was no allegation of patient death or serious injury.
Additional Manufacturer Narrative
Additional information: g4, h3, h6 h3 evaluation summary: one device was received for evaluation.The reported event was confirmed.The device failed to meet specification as it was received or made available for evaluation.The front housing and top cover are damaged.The equipment is ready to use and safe for the patient according to the manual manufacturer's standards.Functional test with approved success.Battery must be replaced every two years as indicated in the service manual.The investigation of observed condition isolated the failure to the damaged housing and old battery.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: 9398110
• Report Number: 2936999-2019-00982
• Device Sequence Number: 16869685
• Product Code: DQA
• UDI-Device Identifier: 10884521582484
• UDI-Public: 10884521582484
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K021090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1