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

Model Number N560

Device Problem Low Readings (2460)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2020

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 patient had low saturation on 83-89% on monitor using battery power.The patient was tried to another monitor which was plugged on main, it was observed for full 10 minutes and consistently above 97%.Checked with third monitor for corroboration, also reading saturation above 97%.The unit was fully tested and all of the outputs on the spo2 monitor were within specification.There was a slight lag when the unit was tested on battery power but the results were within operating range.There was no reported patient outcome.

• Brand Name: OXIMAX
• Type of Device: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 10959063
• MDR Text Key: 219901913
• Report Number: 2936999-2020-00911
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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?: No
• Date Manufacturer Received: 11/13/2020
• 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