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

Model Number 21317

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer 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.

Event Description

The customer reported when the handheld is connected to rds it reboots (you go inside the menu and it come back to main screen, also all rds leds remain lighted), is like this always.Handheld works properly out of the rds, but battery is discharged too soon.No patient impact or consequences reported.

Manufacturer Narrative

Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned device was evaluated.During this testing the unit was able to power on using both ac and battery power.The device was able to obtain readings and alarmed audibly and visually under alarm conditions.When docked in the customer's docking station the device was unable to communicate with the docking station causing all of the indicator leds to illuminate and the display to constantly restart.Alarm alerts were not visible on the docking station's led indicators.The customer's battery was charged for 24 hours and the battery icon was not full, indicating the battery is unconditioned and unable to charge completely.The device remained on for a few minutes before a low battery alarm was present.A review of the history for this device was performed and it was concluded that the device was in the field for over four (4) years with no previous returns for servicing or other issues prior to the reported event, corrected data:.

• 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: charlene johnson ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6341915
• MDR Text Key: 67814345
• Report Number: 2031172-2017-00228
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 21317
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2010
• 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
• Treatment: DOCKING STATION