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

Model Number N5600PLUS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 09/10/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, something happened during the operation of the device by the hospital staff and the patient died.When malfunction of device was realized, patient was immediately connected to another device and vital functions were monitored during whole cardiopulmonary resuscitation with working monitor.The device reached its end of service life but it was continuously used.

• Brand Name: OXIMAX OXIMETER
• 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 ; 5920 longbow drive; boulder, CT 80301 ; 3035306582
• MDR Report Key: 10655970
• MDR Text Key: 210620008
• Report Number: 2936999-2020-00726
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N5600PLUS
• Device Catalogue Number: N5600PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Date Device Manufactured: 06/08/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 54 YR