MAUDE Adverse Event Report: COVIDIEN-MEDTRONIC NELLCOR NEONATAL-ADULT SPO2 SENSOR PULSE OXIMETER

Model Number MAX-N

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

45 year old male admitted on (b)(6) 2023 for further evaluation and treatment for alcohol intoxication.On (b)(6), night to day change of shift, the oncoming and off going rn's (registered nurses) "thought they detected a burning smell", but did not investigate further.Day shift charge rn reported to the progressive care unit clinical supervisor that a spo2 sensor had been found on the patient that "looked like it had been burned".The patient's finger and hand were assessed and no injuries were identified.The event itself was unwitnessed.The device had charring with the cable sleeve melted, extending from attachment point to the patient to approximately 1 inch below the attachment point.The patient was discharged to home on (b)(6) 2023.

• Brand Name: NELLCOR NEONATAL-ADULT SPO2 SENSOR PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN-MEDTRONIC
• MDR Report Key: 17810765
• MDR Text Key: 324277857
• Report Number: MW5146118
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2023

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: MAX-N
• Device Lot Number: 231560102H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2023
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White