MAUDE Adverse Event Report: MEDIANA NELLCOR; OXIMAX N560 PULSE OXIMETER

Model Number N560

Device Problems Display or Visual Feedback Problem (1184); Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The found failure of missing segments is a known issue and action has been taken under remedial action efforts.Complaint trends will continue to be monitored.

Event Description

During analysis of the unit, it was observed that the segments were missing on the display.There was no patient involved.

• Brand Name: NELLCOR
• Type of Device: OXIMAX N560 PULSE OXIMETER
• Manufacturer (Section D): MEDIANA; wonju industry park; dongwha-ri,munmak-eup wonju-si; gangwon-do ; KS
• Manufacturer (Section G): MEDIANA; wonju industry park; dongwha-ri,munmak-eup wonju-si; gangwon-do ; KS
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6351615
• MDR Text Key: 68368750
• Report Number: 2936999-2017-00121
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Date Manufacturer Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2268-2015
• Patient Sequence Number: 1