MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET NEO; OXIMETER

Model Number 4003

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device involved in this event was not returned as it has been retained by the hospital.If new information is obtained, a follow up report will be submitted.

Event Description

Customer reported "patient said he was shocked and caused a spark while wearing the (4003) sensor and urinating.We informed him that couldn't be the case.He kept telling anyone who listed what happened.The patient stated he did a (b)(6) search for masimo and shock and came up with "a ton of articles" all of which were about septic shock, not a shock from medical equipment." the customer is performing an internal investigation and will not be releasing the device at this time.Per the customer, this involved a 4003 sensor and radius 7 24949 and 24950.

• Brand Name: RD SET NEO
• 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: 6324482
• MDR Text Key: 67253192
• Report Number: 2031172-2017-00187
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RADIUS-7
• Patient Outcome(s): Other