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

Model Number 10005941

Device Problems No Audible Alarm (1019); Image Display Error/Artifact (1304); Defective Component (2292); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the speaker in the monitor was defective.It was reported that the product gave an error message of error code 910.The reported issue was confirmed.The most likely cause was traced to a component failure.It was also reported that the jog dial on the pulse ox monitor needed to be replaced.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during service and repair, the device had noise and was not working properly, sounds did not come clear and had an error 910 that was related to speaker and had jog dial malfunction.Medtronic's initial evaluation of the incident device found that the device had defective speaker where sounds did not come clear.

• 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 ; KS 00000
• Manufacturer (Section G): MEDIANA CO. LTD.; 1650 1 2 donghwa ri munmak eu; kangwon do wonju si 00000 ; KS 00000
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12068193
• MDR Text Key: 258407213
• Report Number: 2936999-2021-00617
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10884521163454
• UDI-Public: 10884521163454
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K120773
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• 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: 05/28/2021
• Date Manufacturer Received: 06/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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