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

Model Number	N600X-1
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Bronchopneumonia (2437)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, postoperatively, the unit did not alarm.This was used on a patient paralyzed from neck down, who was on a 24/7 ventilator with fitted pacemaker and was fed using a peg tube.The patient died because of pneumonia, which was not attributed to the device used.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway ; EI
• MDR Report Key: 11940049
• Report Number: 8020893-2021-00082
• Device Sequence Number: 19970460
• Product Code: DQA
• UDI-Device Identifier: 10884521181229
• UDI-Public: 10884521181229
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: N600X-1
• Device Catalogue Number: N600X-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1