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

Model Number N-BSJP

Device Problem Computer Operating System Problem (2898)

Patient Problem Death (1802)

Event Date 02/11/2019

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 device displayed zero respiratory and heart rate at 16:40 but on the other unit it was displayed 99 spo2 and 150 heart rate.It was also stated that the device was turned off and the sensor was removed after noticing that it was still remaining on the values stated.The beep sound was managed silence in the hospital and so the device was not sounding.The patient death was confirmed at 18:20 but the clock on the device displayed 7:26 at 9:13.A gap was found by 1 hour and 47 minutes.The cause of death was unknown.

• Brand Name: NELLCOR 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: 8418371
• MDR Text Key: 138721040
• Report Number: 2936999-2019-00184
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• 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
• Date Manufacturer Received: 02/17/2019
• 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
• Patient Age: 80 YR