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

Model Number 20308

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.During inspection, the unit was found to be able to visually alarm during alarm conditions, however no audible tones were emitted.The speaker was replaced, and the device functioned as designed.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.

Event Description

The customer reported an alarm failure with a radical handheld device.No patient impact or consequences were reported.

• Brand Name: RADICAL 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: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6699973
• MDR Text Key: 79631685
• Report Number: 2031172-2017-00703
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040214
• 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: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20308
• Device Catalogue Number: 1708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2001
• 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