MAUDE Adverse Event Report: MEDIANA CO. LTD. LIBRA BEDSIDE SPO2 MONITOR; OXIMETER

Model Number N-BSJP

Device Problem Failure to Sense (1559)

Patient Problem Death (1802)

Event Date 06/04/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient died, however according to the display message, but spo2 was 100% and the value of pr was indicated around 200.The alarm values of spo2 and pr were default setting, and they did not know whether alarm had been generated or not.Oxygen had been administered, since oxygen flow was adjusted while watching the value of spo2 until the previous day, value change had been confirmed.The issue that the value (of spo2) did not change from 100% and pr was indicated around 200 in the situation that the patient was died was requested to be investigated.

• Brand Name: LIBRA BEDSIDE SPO2 MONITOR
• 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, CO 80301 ; 3035306582
• MDR Report Key: 8755243
• MDR Text Key: 149850995
• Report Number: 2936999-2019-00445
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N-BSJP
• Device Catalogue Number: N-BSJP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• 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
• Patient Outcome(s): Death