MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY EMMA (MMHG) CAPNOGRAPH KIT; OXIMETER

Model Number 18265

Device Problem Low Readings (2460)

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

Event Date 09/20/2021

Event Type  malfunction  

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 Description

The customer reported the device gave inaccurate readings, low co2.No patient impact or consequences were reported.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• MDR Report Key: 12643495
• MDR Text Key: 278452090
• Report Number: 3019388613-2021-00282
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 07350046131750
• UDI-Public: 07350046131750
• Combination Product (y/n): N
• PMA/PMN Number: K063167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18265
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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