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

Model Number	26040
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported inaccurate readings on capnography co2.No patient impact or consequences were reported.
Event or Problem Description
The customer reported inaccurate readings on capnography co2.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other text: the returned device was evaluated.External visual inspection found no damage or defects.The device was able to power on and obtain readings.The device alarmed audibly and visually under alarm conditions.The capnography module was removed for accuracy testing.The module was connected to the test software and no errors or failures were observed.When no gas mixture is applied and no breaths are present the module measured outside the accuracy specification.A zero calibration was performed and the device now measured within the accuracy specification.Incorrect gas span calibration zeroing resulted in measurements outside the accuracy specification.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.

• Brand Name: RAD-97 W/CAPNOGRAPHY
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 12003801
• Report Number: 3011353843-2021-00139
• Device Sequence Number: 13705441
• Product Code: MWI
• UDI-Device Identifier: 00843997012782
• UDI-Public: 00843997012782
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 05/26/2021

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: 06/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1