MAUDE Adverse Event Report: MEDIANA CO. LTD. PULSE OXIMETER

Model Number N560

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, upon plugging the power cord into the unit, there were sparks and presence of burnt smell.There was no patient harm.

Manufacturer Narrative

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

• Brand Name: PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): MEDIANA CO. LTD.; 1650-1 donghwa-ri, munmak eup; wonju-si, gangwon-do 220-8 01; KR 220-801
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650-1 donghwa-ri, munmak eup; wonju-si, gangwon-do 220-8 01; KR 220-801
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 7390863
• MDR Text Key: 104159999
• Report Number: 2936999-2018-00217
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• 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
• Device Lot Number: CX07048009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No
• 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