MAUDE Adverse Event Report: NONIN MEDICAL, INC. NONIN; OXIMETER

Model Number 7000A

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

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Using new continuous pulse ox sensors model 7000a.Staff have been noticing that he sensors are not accurately reading o2 levels.They often have to be changed and still do not read accurately or do not pick up at all.Patient was in nuclear medicine and the telemetry was reading an oxygen level of low 70's to 60's the primary nurse went to check on patient and upon obtaining a oxygen level with a dyna map machine the patient was actually 100% telemetry was still reading 71%.

• Brand Name: NONIN
• Type of Device: OXIMETER
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st ave, north; plymouth MN 55441
• MDR Report Key: 13964558
• MDR Text Key: 288288607
• Report Number: 13964558
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7000A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Female