MAUDE Adverse Event Report: MASIMO CORPORATION RED LNC-10 PATIENT CABLE

Model Number 2056

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

The following was reported to the customer by an end user that the end-user's reported of inaccurate spo2 readings when using the rad-8, patient cable pn-2056 and disposable sensors pn-2329.The end-user indicated that the readings from the rad-8 for spo2 fluctuated between 90 percent and 70 percent rapidly within seconds.There was no reported behavior with pulse rate readings.They stated that this problem has occurred even while the patient was sleeping or not moving.The end-user did not use other means to verify the saturation on the patient.They did not notice any changes in the patient before or after event first took place.The mother stated that the patient is in a bedroom environment, non-smoking and on a hospital bed.The mother switched to new disposables every two days.They stated that they change it earlier if they notice inaccuracies with the spo2.The end-user was unable to determine if switching to new disposables have solved the issue.The mother administered oxygen to patient in response to the event and there were no changes observed.No patient incident reported.

Manufacturer Narrative

Multiple attempts for product return and additional information requests were made.The unit was not returned to allow an analysis to be performed.If new information is obtained, a follow up report will be submitted.No patient incident reported.

• Brand Name: RED LNC-10 PATIENT CABLE
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXCICALI, S.A. DE C.V.; calzada del oro no. 2001; parque industrial palaco
• Manufacturer Contact: jodi swindle ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4081085
• MDR Text Key: 4741147
• Report Number: 2031172-2014-00150
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2056
• Device Catalogue Number: 2056
• Device Lot Number: A11B119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 6 YR