MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-97 W/CAPNOGRAPHY; OXIMETER

Model Number	26040
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.The unit powered on and off using both battery and ac power.The device passed functionality testing; however measured outside the accuracy specification when connected to the lab gas master application.A zero calibration was performed on the module and measurements were within the acceptable accuracy specification.Incorrect gas span calibration zeroing resulted in measurements outside the accuracy specification.Gas span calibration is automatically performed periodically.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the rad-97 provided inaccurate etco2 readings.No consequences or impact to patient were reported.

• Brand Name: RAD-97 W/CAPNOGRAPHY
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12485387
• Report Number: 3011353843-2021-00243
• Device Sequence Number: 14386682
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: 00843997012782
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170168
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 26040
• Device Catalogue Number: 9799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1