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

Model Number N560

Device Problem Device Alarm System (1012)

Patient Problem Death (1802)

Event Date 06/25/2019

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a normal use, the device did not trigger an alarm.The patient, who was in a coma, had a cardiac arrest and died.

Manufacturer Narrative

Additional information: (date of birth), evaluation summary: one sample was evaluated.Service investigation was performed on the device.Performance testing confirmed the device works as intended and the alarm is activated as expected and the speaker is working and audible.The trend memory of the device (nat file) was downloaded and analyzed.The logged data clearly indicates the alarm limits and events.The events show the low spo2 and both high and low pulse rate alarms triggering, along with various ¿alarm silence¿ events.The ¿alarm silence¿ events mean the alarm silence was being manually pressed.The logged alarm silence events were performed.The manual silencing of the alarms explains how there would be no alarm when the system was functioning normally.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.

Event Description

According to the reporter, during a normal use, the device did not trigger an alarm.The patient, who was in a coma, had a cardiac arrest and died.The care facility was informed by phone that the pulse oximeter must first be kept in the facility for a period of 2 weeks.Patient had multiple sclerosis.

• 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: 8814397
• MDR Text Key: 151832216
• Report Number: 2936999-2019-00484
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR