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

Model Number 10005941-SG

Device Problems Device Alarm System (1012); No Display/Image (1183); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the device had turned black when inspecting the ward and there was no alarm.Failed to observe the condition in time due to being in standby state for a long time and there were problems with internal parts or circuits.It was replaced it with another pulse oximeter, and continued monitoring vital signs, and clearly identified the fault.There was a patient serious injury reported.

• 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 ; KS 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15592653
• MDR Text Key: 301628002
• Report Number: 2936999-2022-00930
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

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: 10005941-SG
• Device Catalogue Number: 10005941-SG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/12/2022
• 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: 42 MO
• Patient Sex: Female