MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7; OXIMETER

Model Number 21317

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 07/07/2016

Event Type  Death  

Manufacturer Narrative

The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.

Event Description

Masimo received a request by customer to provide alarm history of device involved in a "medical incident." upon clarification the "medical incident" was described as a "patient collapse." masimo was later informed that the patient expired "a few days after the incident." no further details provided.

Manufacturer Narrative

The device was returned and evaluated and was found to function as designed.During the investigation, the device was found to power-on using both ac and dc power.The display was bright, clear and functioned normally.The unit was capable of engaging in monitoring using the masimo set tester module and when tested using a sensor.The unit alarmed both audibly and visually.The unit also alarmed when the spo2 and bpm alarm limits were triggered.

• Brand Name: RADICAL-7
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 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: 5865406
• MDR Text Key: 51745211
• Report Number: 2031172-2016-00894
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K140188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21317
• Device Catalogue Number: 9500
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2009
• 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
• Patient Outcome(s): Death; Other; Required Intervention