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

Model Number 21317

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/20/2017

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

Customer reported a "defective radical 7.Regular reset of the measurement with mains operation".No known impact or consequence to patient.

Manufacturer Narrative

Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned device was evaluated.During evaluation, the radical-7 display resets every few seconds.The failure was isolated to a recessed pin (pin 12) causing the radical-7 to be unable to communicate with the docking station.The communication failure results in the radical-7 display to reset every few seconds, for less than a second.The unit's functionality with regard to monitoring remained unaffected by the failure.The radical-7 was found able to obtain values and to visually and audibly alarm during alarm conditions.A service history record review reveals that this unit was in the field for over seven (7) years with no previous reported issues prior to this reported event.

• 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: stefan lissmann ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 6463552
• MDR Text Key: 72443483
• Report Number: 2031172-2017-00416
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K140188
• 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: 04/06/2017
• 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: 04/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2010
• 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