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

Model Number PM10N

Device Problems Device Emits Odor (1425); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one sample of device was received for evaluation.Unable to verify burn smell.The uut was received in the failure analysis department with the keypad replaced.The spo2 connector on the main board was found to have solder defects due to workmanship (see image).The spo2 connector was found lifted from the main board.The back housing of the battery cover was found to have corrosion due to ingress from an unknown substance.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.

Event Description

According to the reporter, the device had damaged keyboard membrane and a burning smell when turned on.The customer indicated no patient harm.

• 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: 9438545
• MDR Text Key: 169908629
• Report Number: 2936999-2019-01002
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: 20884521208787
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 11/15/2019
• 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