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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 PM100N
Device Problems Charging Problem (2892); Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2022
Event Type  malfunction  
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, during servicing, the device power supply burned.
 
Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The analysis found that there was a burnt trace on the circuit board, and there was an issue with the power supply.It was reported that there were signs of a thermal issue (hot, smoke, smell or actual flame), and the monitor did not charge the battery.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing 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.
 
Event Description
According to the reporter, during servicing, the device power supply burned.The device worked until the battery ran flat and could not charge.
 
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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, CO 55112
7635265677
MDR Report Key14889648
MDR Text Key303217506
Report Number2936999-2022-00590
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10884521196728
UDI-Public10884521196728
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K142865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/07/2022
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 NumberPM100N
Device Catalogue NumberPM100N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2022
Initial Date Manufacturer Received 06/21/2022
Initial Date FDA Received07/01/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received09/07/2022
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
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