MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8; OXIMETER

Model Number 22043

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/09/2017

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.(b)(6).

Event Description

It was reported that no permanent failure, but when hitting on the housing, the device is restarting.Maybe a problem on the system board.Per the customer, no error message or alarm when the device restarted.No known impact or consequence to patient.

Manufacturer Narrative

The returned device was evaluated.During evaluation the unit was able to power on, however, the device reboots when device is physically hit with significant force or when device is drop from about (b)(4) inches.The failure was isolated to the clock for the ui board mcu (y2).Applying pressure to y2 results in the device rebooting.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues prior to this reported event.

• Brand Name: RAD-8
• 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: gail hapner ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6393863
• MDR Text Key: 69572598
• Report Number: 2031172-2017-00309
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 22043
• Device Catalogue Number: 9191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• 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