MAUDE Adverse Event Report: COVIDIEN NELLCOR BEDSIDE RESPIRATORY PATIENT MONI; OXIMETER

Model Number PM1000N

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Dyspnea (1816); Hypoxia (1918)

Event Date 01/21/2021

Event Type  Injury  

Event Description

Patient's bedside oxygen saturation monitor checks were indicating 100% even though he did not look well, he was short of breath and hypoxic.The resident used his portable o2 sat monitor that he purchased on (b)(6) and it showed patient's o2 sat in the low 8)s.Abg's were performed and showed o2 sat at 68.The patient was transferred to the icu for monitoring.Fda safety report id # (b)(4).

• Brand Name: NELLCOR BEDSIDE RESPIRATORY PATIENT MONI
• Type of Device: OXIMETER
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11259881
• MDR Text Key: 229847627
• Report Number: MW5099099
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): Y
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM1000N
• Device Catalogue Number: PM1000N
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Weight: 74