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

Model Number N-BSJP

Device Problems False Alarm (1013); Image Display Error/Artifact (1304); Low Readings (2460)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the device had inconsistent spo2 readings, switching from 90 to 75 and the alarm was heard continuously.After the spo2 reading was changed to 90 again, eee804 occurred.There was no patient involvement.

Manufacturer Narrative

Additional information: d8, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The issue was res olved by replacing the nell board as a precaution.It was reported that the device had inconsistent spo2 readings.The reported issue could not be confirmed.The most likely cause was traced to component failure.This issue may occur due to faulty spo2 pcb.The ma nufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIBRA BEDSIDE 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
• MDR Report Key: 8616608
• MDR Text Key: 145636340
• Report Number: 2936999-2019-00347
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: N-BSJP
• Device Catalogue Number: N-BSJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1