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

Model Number 9190

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/04/2015

Event Type  Death  

Manufacturer Narrative

Additional manufacturing narrative: the device history record (dhr) was reviewed and it was determined that the device met all release criteria, 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.

Event Description

It was reported: "the following information was alleged in a complaint filed by plaintiff (b)(6), et-al, (reference #(b)(6)) related to masimo¿s rad 8 pulse oximeter: ¿on or before the (b)(6) 2015, [the patient] required a masimo rad 8 pulse oximeter which failed.¿ ¿said design, manufacture, assembly, installation, repair, modification, maintenance, servicing, sale and/or distribution was performed by defendants, at home medical, masimo, abc corporation, xyz partnership (representing a series of fictitious names), in a negligent, reckless and careless manner as a result of which plaintiff [the patient], sustained serious, painful and permanent injuries and death.¿ ¿as a matter of fact, said masimo rad 8 pulse oximeter and/or its components were not designed, manufactured, assembled, installed, repaired, modified, maintained, serviced, sold and/or distributed in a proper manner, fit, safe and suitable for the use intended, as a result of which plaintiff sustained the damages and losses referred to above.".

• Brand Name: RAD-8, HORIZONTAL
• 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: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 7521047
• MDR Text Key: 108479638
• Report Number: 2031172-2018-00286
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9190
• Device Catalogue Number: 9190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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
• Patient Outcome(s): Death