MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY EMMA CAPNOGRAPH, KPA; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 18266

Device Problem Low Readings (2460)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

The customer reported the device showing low reading on 5% co2.No consequences or impact to patient were reported.

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.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).

Event Description

The customer reported the device showing low reading on 5% co2.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.The emma measured outside of the specification range for co2 measurements because it was not zeroed out as part of the preventative maintenance.Once the zeroing procedure was completed, the measured value was within the specified range.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).

• Brand Name: EMMA CAPNOGRAPH, KPA
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 16445706
• MDR Text Key: 310350357
• Report Number: 3019388613-2023-00046
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 07350046131040
• UDI-Public: 07350046131040
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18266
• Device Catalogue Number: 3678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1