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U.S. Department of Health and Human Services

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

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MEDIANA CO. LTD. NELLCOR; OXIMETER Back to Search Results
Model Number 10005941J
Device Problem Delayed Program or Algorithm Execution (4034)
Patient Problem Insufficient Information (4580)
Event Date 10/13/2023
Event Type  Death  
Manufacturer Narrative
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.
 
Event Description
According to the reporter, when the patient arrived in day service, the patient lips were purple (pale) and had stopped breathing, and was suffering a cardiac arrest.It was noticed that the patient wore monitors, added oxygen, and carried out bagging.During the period of cardiac arrest, his spo2 reading was 93%, so it was noticed late.The physician's comments were there was able to be no palpable findings of the pulse, about the auscultation was heard after starting chest compressions.Other monitors were not used.The monitor was removed when the aed pad was attached.The patient died.The patient death is not device related.
 
Event Description
According to the reporter, when the patient arrived in day service, the patient lips were purple (pale) and had stopped breathing, and was suffering a cardiac arrest.It was noticed that the patient wore monitors, added oxygen, and carried out bagging.During the period of cardiac arrest, his spo2 reading was 93%, so it was noticed late.The physician's comments were there was able to be no palpable findings of the pulse, about the auscultation was heard after starting chest compressions.Other monitors were not used.The monitor was removed when the aed pad was attached.The patient died.The patient's death is not device related.
 
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 monitor had a delay in updating the oxygen/respiratory rates.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.The instructions included with this device provide the following guidance: it is recommended for regular battery replacement every two years due to aging deterioration, please consider replacing the battery based on the number of years of use.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.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.
 
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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 Key18131883
MDR Text Key328058797
Report Number2936999-2023-01063
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120773
Number of Events Reported1
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 01/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10005941J
Device Catalogue Number10005941J
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Death;
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