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

Model Number 10005941J

Device Problems Device Alarm System (1012); Image Display Error/Artifact (1304)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, readings suddenly stopped displaying without any alarm.Only the error message eee010 appeared in the bottom left.There was no reported patient outcome or involvement.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the product had an issue with the alarm system and the product gave an error message of error 10.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 ; KS 00000
• MDR Report Key: 12134928
• MDR Text Key: 260465821
• Report Number: 2936999-2021-00658
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K120773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10005941J
• Device Catalogue Number: 10005941J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1