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

Model Number N65P

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2019

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 unit had a several missing segments.It was reported that the batteries were replaced.There was no patient involvement.

Manufacturer Narrative

Evaluation summary: service personnel reported: the complaint was verified, but a component level root cause was unable to be determined.The cause of the issue was isolated to the user interface pcb.Another issue was found where two screws had corrosion due to fluid ingress.The exterior casing was intact on arrival.Corrosion was found on the top screws on the back of the device.Known good batteries were installed, and the device was powered on.The device was able to detect the device when plugged in, and was able to operate without errors occurring.The numbers displayed were occasionally missing certain segments.An internal investigation was performed, but no other visible signs of corrosion or damage were found.The user interface pcb was replaced with a known good component, and the missing display segment issue was resolved.Information has been added to the database and trends will continue to be monitored.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: OXIMAX
• 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: 8937088
• MDR Text Key: 156713290
• Report Number: 2936999-2019-00573
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521181243
• UDI-Public: 10884521181243
• Combination Product (y/n): N
• PMA/PMN Number: K051352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N65P
• Device Catalogue Number: N65P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1