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

Model Number N20E

Device Problems Poor Quality Image (1408); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the display is missing segments.The customer reported that within the oxygen saturation, the third character "0" is missing the top left segment.It was indicated that there was no patient involved.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7747078
• MDR Text Key: 116217338
• Report Number: 2936999-2018-00486
• Device Sequence Number: 0
• Product Code: DQA
• Reporter Country Code: US
• PMA/PMN Number: K915699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N20E
• Device Catalogue Number: N20E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1