MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL 7; OXIMETER

Model Number 23789

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.(b)(6).

Event Description

It was reported that "display changed by itself without touching and unable to change the brightness by touching".No known impact or consequence to patient.

Manufacturer Narrative

The returned device was evaluated.During evaluation, the unit was able to turn on; however, the screen was scrolling by itself.It was determined that the touchscreen was defective, causing the screen to change without being touched.As a result, the device was not able to engage in active monitoring.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues prior to this reported event.The customer zip code exceeded maximum allowable digits, zip code is as follows: (b)(6).

• Brand Name: RADICAL 7
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 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: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6344463
• MDR Text Key: 67823690
• Report Number: 2031172-2017-00233
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23789
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: 03/12/2018
• Supplement Dates FDA Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2013
• 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