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

Model Number 10005941

Device Problems Device Alarm System (1012); Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Failure to Sense (1559)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The device failed to meet specification as it was received or made available for evaluation.There was no fault found with respect to the customer complaint but the cause of the observed conditions was determined to be potential user mishandling.The product relates to the reported complaint event.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.

Event Description

According to the reporter, during use, the device had no alarm to alert the event and no spo2 reading with error messages.Patient was desaturated and now on a ventilator.

• 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: 9175440
• MDR Text Key: 161920778
• Report Number: 2936999-2019-00837
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521163454
• UDI-Public: 10884521163454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2019

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
• Device Catalogue Number: 10005941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/10/2019
• 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): Other
• Patient Weight: 64