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

Model Number PM10N

Device Problem Device Emits Odor (1425)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, when new batteries were put in the device, they got extremely hot causing burn on the hand when they were removed.The burn was not bad enough to seek professional medical care.No smoke was seen, the device just did not power on.

Manufacturer Narrative

The event is no longer considered a malfunction, and is now classified as not reportable.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8438045
• MDR Text Key: 139417091
• Report Number: 2936999-2019-00212
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: 20884521208787
• Combination Product (y/n): N
• PMA/PMN Number: K141542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1