MAUDE Adverse Event Report: MASIMO CORPORATION RC-12 PATIENT CABLE; OXIMETER

Model Number 2404

Device Problem Invalid Sensing (2293)

Patient Problem Death (1802)

Event Date 04/11/2015

Event Type  Death  

Event Description

It was reported that a (b)(6) baby (preterm) (b)(6), nicu 3rd diagnosed with immaturity/rds was being monitored with a rad-87 device and neo sensor.The neonatologist states that the patient expired.Resuscitation was performed with no pulse.The spo2 was still reading 100% and pr was 66 bpm.The device's serial was not recorded.As such, the customer will not be able to send the device in for evaluation.

Manufacturer Narrative

Attempts for the return of the cable as well as additional info request have been made in order to identify the cable involved in the reported event.It was indicated that the customer did not know which cable was involved in the reported event as the lot number was not recorded.If new info is obtained, a f/u report will be submitted.

• Brand Name: RC-12 PATIENT CABLE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A.
• Manufacturer Contact: charlene johnson ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4847642
• MDR Text Key: 20065525
• Report Number: 2031172-2015-00839
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2404
• Device Catalogue Number: 2404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 5 DA