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

Model Number	N560
Medical Device Problem Code	Device Alarm System (1012)
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 unit had an issue with the alarm.There was no allegation of patient death or serious injury associated with this event.
Additional Manufacturer Narrative
Evaluation summary: one unit was evaluated.It was inspected and the reported issue was verified.The front, top and bottom cover was broken and also the interface, screws and rubber feet was missing.The battery is too old and needs to be replaced.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure to the defective keyboard and the dib pcba card.The failure relates to the reported complaint event.Complaint trends will be reviewed and monitored.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: 9293592
• Report Number: 2936999-2019-00925
• Device Sequence Number: 2363080
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1