MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-87; OXIMETER

Model Number 22742

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Visual evaluation revealed stress cracks on the top side and back side of the device.During evaluation the unit was able to power on, however, the alarms were not audible.The device displayed the system error code 5 (speaker fault).The input pins (j2) for the speaker on the system board were damaged and caused the speaker to malfunction.The speaker was replaced and the unit functioned as designed.

Event Description

It was reported that the device has a bad speaker.Customer stated, "i discovered the broken speaker connector on the pcb." the unit was able to engage in monitoring activities.No known impact or consequence to patient.

• Brand Name: RAD-87
• 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: 6511067
• MDR Text Key: 73382618
• Report Number: 2031172-2017-00490
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091241
• 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: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22742
• Device Catalogue Number: 9226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2010
• 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