MAUDE Adverse Event Report: MASIMO CORPORATION RAD-8 HORIZONTAL MS-2000; OXIMETER

Model Number 22042

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Customer reported that "upon initial setup/turn on, the unit cycles on and off with a popping sound.After a couple cycles it makes a screeching sound." no pt involvement.

Manufacturer Narrative

The device has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

• Brand Name: RAD-8 HORIZONTAL MS-2000
• 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: 4321843
• MDR Text Key: 5245137
• Report Number: 2031172-2014-00492
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 22042
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1