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

Model Number N560

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

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 does not mark the digits well.There was no allegation of patient death or serious injury.

Manufacturer Narrative

Additional information: g4, h3, h6 h3 evaluation summary: one device was received for evaluation.The reported event was confirmed.The device failed to meet specification as it was received or made available for evaluation.The front housing and top cover are damaged.The equipment is ready to use and safe for the patient according to the manual manufacturer's standards.Functional test with approved success.Battery must be replaced every two years as indicated in the service manual.The investigation of observed condition isolated the failure to the damaged housing and old battery.No new formal investigation is required, the event will be included in trending and monitoring.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
• MDR Report Key: 9398110
• MDR Text Key: 169236406
• Report Number: 2936999-2019-00982
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521582484
• UDI-Public: 10884521582484
• Combination Product (y/n): N
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

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 Number: N560
• Device Catalogue Number: N560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1