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

Model Number 21744

Device Problems Failure To Run On AC/DC (1001); Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.The radical-7 handheld device passed visual inspection; however visual inspection of the docking station (rds) indicated a broken latch.The radical-7 functioned as designed in a known good docking station.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.The handheld was unable to stay docked due to the rds damage and as a result was unable to maintain communication and power between rds and radical-7.Due to loss of power the radical-7 will power off when battery power is depleted.

Event Description

The customer reported the device powers off and has as damaged housing.No patient impact or consequences were reported.

• Brand Name: RADICAL-7 HANDHELD
• 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: 7347462
• MDR Text Key: 102906008
• Report Number: 2031172-2018-00145
• 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
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21744
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2008
• 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