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 Date 01/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported failure of 'unit display was missing segments' was verified.The reported customer complaint is a known issue and has been isolated and action has been taken under remedial action efforts.Please see section for remedial action reference.Complaint trends will continue to be monitored.

Event Description

The reporter stated the n560 pulse oximeter display was missing segments.There was no patient involvement with this event.

• 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; KS
• Manufacturer Contact: ray maroofian ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6256543
• MDR Text Key: 65365739
• Report Number: 2936999-2017-00047
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2012
• 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