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

Model Number	PM1000N-RR
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
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
Medtronic received report that during setup, satseconds feature was not alarming when circle filled.It had a delay of approximately 30 seconds.No patient impact was reported.

• Brand Name: NELLCOR PULSE OXIMETER
• 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: 7035711
• Report Number: 2936999-2017-05618
• Device Sequence Number: 19182110
• Product Code: DQA
• UDI-Device Identifier: 10884521182547
• UDI-Public: 10884521182547
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2017

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: PM1000N-RR
• Device Catalogue Number: PM1000N-RR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1