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

Model Number 2653

Device Problem Sensing Intermittently (1558)

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

Event Date 11/01/2022

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 was tested and the results were intermittent.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: additional information: d4.(lot) was updated from "22fup" to a blank field.D4.(udi #) was updated from (b)(4) to a blank field.H4.Was updated from "06/20/2022" to a blank field.The returned sensor was evaluated.A visual inspection identified green corrosion at the copper detector shield.Continuity testing revealed an intermittent open connection in the cable on the detector circuit at the bend relief area of the db9 connector.When the sensor is manipulated, both the corrosion and open circuit contributed to the sensor's intermittent behavior.Audible and visual alarms were triggered on the lab monitor during the intermittent events.

Event Description

The customer reported the sensor was tested and the results were intermittent.No consequences or impact to patient were reported.

• Brand Name: LNCS DBI
• 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: 15909268
• MDR Text Key: 304781758
• Report Number: 3019388613-2022-00257
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997003094
• UDI-Public: 00843997003094
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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: 2653
• Device Catalogue Number: 2653
• Device Lot Number: 22FUP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/07/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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