MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY NOMOLINE; OXIMETER

Model Number 4410

Device Problem Incorrect Measurement (1383)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.When co2 gas mixture was applied, the isa module measured outside the accuracy specification.After gas span calibration zeroing was performed and a co2 gas mixture was applied, the isa module measured within the accuracy specification.Incorrect gas span calibration zeroing resulted in measurements outside accuracy specification.S.

Event Description

The customer reported "bad results / reading." no patient impact or consequences were reported.

• Brand Name: NOMOLINE
• Type of Device: OXIMETER
• 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16078155
• MDR Text Key: 306535188
• Report Number: 3019388613-2022-00279
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2022

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
• Device Operator: Health Professional
• Device Model Number: 4410
• Device Catalogue Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• 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