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

Model Number	N65-1
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/14/2018
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, the device had a defective screen display and incomplete numbers.It was reported that number nine was displayed as five.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: the device had defective screen display and incomplete numbers.It was reported that number nine was displayed as five.The customer reported that there was no patient involvement.The product was evaluated.Service personnel reported the following: verified complaint.Parts were obsolete.The device failed to meet specification as it was received or made available for evaluation.The investigation isolated the failure to the display.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.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): NELLCOR PURITAN BENNETT IRELAND; micheal collins rd mervue; galway
• MDR Report Key: 8119580
• Report Number: 8020893-2018-00554
• Device Sequence Number: 10813608
• Product Code: DQA
• UDI-Device Identifier: 10884521096738
• UDI-Public: 10884521096738
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K051352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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
• Operator of Device: Health Professional
• Device Model Number: N65-1
• Device Catalogue Number: N65-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1