MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7 HANDHELD; OXIMETER

Model Number 25054

Device Problem No Audible Alarm (1019)

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

Event Date 03/20/2016

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for 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

Customer reported that the radical-7 touchscreen does not audibly alarm when the spo2 alarm limits are exceeded for either high or low settings.However, there is a visual alarm (flashing red bell on the docking station and flashing red highlight behind the spo2 value), but there is no visual error message indicating low or high spo2.The customer confirmed that the speaker was working.The speaker will audibly alarm for initial "sensor off" (and shows the corresponding error message), low and high pulse rate (and shows the corresponding error message), and will also sound during pulse tones and power on.The speaker will also variably sound as adjustments are made to alarm and pulse tone volume settings.No known impact or consequence to patient.

Manufacturer Narrative

The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.

• Brand Name: RADICAL-7 HANDHELD
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.; calzada del oro no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 5542839
• MDR Text Key: 41720474
• Report Number: 2031172-2016-00468
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25054
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2015
• 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