MAUDE Adverse Event Report: COVIDIEN LP NELLCOR; OXIMETER, REPROCESSED

Model Number	MAXAR
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Probes failed to work with alert "no probe" alarming on monitor screen.Attempted exchanging blue cable, blowing out dust from cable plug holes on the brick, unplugging and re-plugging the brick from monitor.All these interventions failed.

• Brand Name: NELLCOR
• Common Device Name: OXIMETER, REPROCESSED
• Manufacturer (Section D): COVIDIEN LP; 6135 gunbarrel ave.; boulder CO 80301
• MDR Report Key: 22008485
• Report Number: 22008485
• Device Sequence Number: 15449940
• Product Code: NLF
• UDI-Device Identifier: 20884522040102
• UDI-Public: (01)20884522040102
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025
• Report Date (Section F): 05/07/2025

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 Model Number: MAXAR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/07/2025