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

Model Number	18265
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product, however, 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.Zip code is as follows: (b)(6).Phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the device is providing 50 points difference when compared to blood sample.No consequences, or impact to patient were reported.
Event or Problem Description
The customer reported the device is providing 50 points difference when compared to blood sample.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed., other, other text: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: 214400 initial reporter phone number exceeded the maximum allowable characters, phone number is as follows: (b)(6).

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10868092
• Report Number: 3011353843-2020-00186
• Device Sequence Number: 11421837
• Product Code: CCK
• UDI-Device Identifier: 07350046131750
• UDI-Public: 07350046131750
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 18265
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1