MAUDE Adverse Event Report: NELLCOR PURITAN BENNETT IRELAND NELLCOR; OXIMETER

Model Number N600X

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 06/21/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device was programmed neo instead of adult, alarms turned down and had an error code of mo.The patient died.

• Brand Name: NELLCOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd; galway ; IE
• Manufacturer (Section G): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd; galway ; IE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 10303452
• MDR Text Key: 199730945
• Report Number: 8020893-2020-00104
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N600X
• Device Catalogue Number: N600X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Date Device Manufactured: 08/15/2012
• 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): Death
• Patient Age: 12 YR