MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO SPO2 UPGRADE KIT PANDA/GIRAFFE; OXIMETER

Model Number 18394

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that the ge panda infant warmer with masimo set board could not obtain reading consistently.No known pt impact was reported.

Manufacturer Narrative

Multiple attempts for product return and requests for add'l info were made.The unit has not been returned to masimo to allow an analysis to be performed.If new info is obtained or the device is returned, a f/u report will be submitted.

• Brand Name: MASIMO SPO2 UPGRADE KIT PANDA/GIRAFFE
• 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: michelle andres ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4317407
• MDR Text Key: 5132733
• Report Number: 2031172-2014-00341
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: GE PANDA INFANT WARMER WITH MASIMO SET BOARD