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

Model Number 10005941-JP

Device Problems Incorrect Measurement (1383); Failure to Sense (1559)

Patient Problem Death (1802)

Event Date 05/31/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit had inaccurate reading.It was reported that the patient died but the spo2 reading was 100 percent.

Manufacturer Narrative

A device was received.The reported event was not confirmed, since the investigation found the product to function normally.The device meet specifications as it was made available for evaluation.No new formal investigation is required since there was no fault found with the product.The product was not related to the reported complaint as no issue was identified.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KR 00000
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8899168
• MDR Text Key: 154486978
• Report Number: 2936999-2019-00542
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521163454
• UDI-Public: 10884521163454
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10005941-JP
• Device Catalogue Number: 10005941-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 04/02/2020
• 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 Number: 1
• Patient Outcome(s): Death