MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RED DCI-DC12; OXIMETER

Model Number 2054

Device Problem Sensing Intermittently (1558)

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

Event Date 12/07/2021

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 sensor has stopped working suddenly, not transmitting any signal.No patient impact or consequences were reported.

Event Description

The customer reported the sensor has stopped working suddenly, not transmitting any signal.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: multiple sensors with multiple lot numbers were returned.The returned sensors were evaluated.Visual inspection found no physical damage.The sensors failed continuity testing and had either a short or open in the cable.During functional testing, the sensors failed and provided either a "sensor off patient" or "replace sensor" error message.One sensor that was returned passed both continuity and functional testing.

• Brand Name: RED DCI-DC12
• 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: 13122317
• MDR Text Key: 284990077
• Report Number: 3019388613-2021-00374
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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
• Device Operator: Health Professional
• Device Model Number: 2054
• Device Catalogue Number: 2054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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