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

Model Number PM10N

Device Problems Incorrect Measurement (1383); Low Readings (2460)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/07/2020

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 an erratic reading.It was reported that they tested the device against different brands and found out that it measured with a 10% difference compared with others which worked with 2 to 3% difference.It was done for at least ten minutes per measurement site and premature fixed equipment was considered reliable.There was no patient outcome reported.

Manufacturer Narrative

This event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

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 child had bronchopulmonary dysplasia and was on the verge of needing extra oxygen, the device measured 85 to 86%.It was reported that the department's meter then measured 95 to 96, then they tested to another device and it measured the same as the department meter.When switched back to alleged defective device, the value dropped directly to 85 to 86%.There was no patient injury.

• 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 ; KR 00000
• MDR Report Key: 9607276
• MDR Text Key: 175672103
• Report Number: 2936999-2020-00052
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: 20884521208787
• Combination Product (y/n): N
• PMA/PMN Number: K141542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1