MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY EMMA (KPA) CAPNOGRAPH KIT; OXIMETER

Model Number	18266
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
Event or Problem Description
The customer reported the device shows too high a value, at 5% co2 it shows 5.9%.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection was performed and found the optical detector lens is recessed.The unit powered on using lab stock batteries.When powered on the device was able to obtain readings and alarmed audibly and visually under alarm conditions.Accuracy testing found co2 measurements outside of the accuracy specification.Following zeroing of the device, the measured value was within the accuracy specification.A recessed optical detector lens may result in clogged adapter alarm or inaccurate readings.Inaccurate readings were corrected following zeroing.A service history record review reveals that this unit was in the field for over six (6) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the device shows too high a value, at 5% co2 it shows 5.9%.No patient impact or consequences were reported.

• Brand Name: EMMA (KPA) CAPNOGRAPH KIT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11282494
• Report Number: 3011353843-2021-00020
• Device Sequence Number: 3498687
• Product Code: CCK
• UDI-Device Identifier: 07350046131743
• UDI-Public: 07350046131743
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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: 18266
• Device Catalogue Number: 3678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1