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

Model Number N-BSJP

Device Problem Delayed Program or Algorithm Execution (4034)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during use, the ecg (electrocardiogram) waveform was flat while the unit continued to display spo2 100%.The patient was in cardiac arrest and the respiratory rate (impedance) was 0.The patient's family were present and felt the spo2 was clearly abnormal so the reading was stopped.The type of lighting used during the measurement was fluorescent light, sensor was applied on finger using auxiliary tape.The patient's cause of death was not known.The patient death is not device related.

Manufacturer Narrative

New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, during use, the ecg (electrocardiogram) waveform was flat while the unit continued to display spo2 100%.The patient was in cardiac arrest and the respiratory rate (impedance) was 0.The patient's family were present and felt the spo2 was clearly abnormal so the reading was stopped.The type of lighting used during the measurement was fluorescent light, sensor was applied on finger using auxiliary tape.The patient's death was not related to device failure.

• Brand Name: LIBRA BEDSIDE
• 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: 18973255
• MDR Text Key: 338522436
• Report Number: 2936999-2024-00502
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• 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: 03/14/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Sex: Female