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

Model Number 10005941-SG

Device Problem Device Alarm System (1012)

Patient Problem Injury (2348)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the device kept making a beeping sound.It was indicated that during detection the display screen was normal and there was no alarm display.The patient had a serious injury.

• Brand Name: NELLCOR
• 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: 10148270
• MDR Text Key: 194947729
• Report Number: 2936999-2020-00414
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521171534
• UDI-Public: 10884521171534
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120773
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10005941-SG
• Device Catalogue Number: 10005941-SG
• Device Lot Number: MBB1609564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2020
• Date Device Manufactured: 10/17/2016
• 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): Other
• Patient Age: 5 DA
• Patient Weight: 3