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

Model Number PM10N

Device Problems Device Stops Intermittently (1599); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); 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, the unit locked up with error message "pisces-boot v1.02.00".It was stated that there was no any allegation of patient death or serious injury.

Manufacturer Narrative

One sample was received for evaluation.The cause of the observed condition was determined to be mother board defective.The product relates to the reported complaint event.The serial number was provided and the service history record for this device was reviewed for similar complaint modes.Similar complaint mode(s) relevant to this complaint were found in the device service history record.Complaint trends will be reviewed and monitored.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 unit locked up with error message "pisces-boot v1.02.00".It was stated that there was any allegation of patient death or serious injury.

• 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, MA 80301 ; 3035306582
• MDR Report Key: 7448932
• MDR Text Key: 106145092
• Report Number: 2936999-2018-00277
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 20884521208787
• UDI-Public: 20884521208787
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

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: PM10N
• Device Catalogue Number: PM10N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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