MAUDE Adverse Event Report: MASIMO CORPORATION RAD-57; OXIMETER

Model Number 21062

Device Problem Invalid Sensing (2293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts for product return and requests for additional information were made.The product has not been returned to masimo to allow an analysis to be performed.If new information is obtained or the product is returned, a follow up report will be submitted.

Event Description

The customer reported devices keep reading high values on spco (+20%) while it should be 0%.No consequences or impact to patient were reported.

• Brand Name: RAD-57
• 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 ; 7142977000
• MDR Report Key: 5504586
• MDR Text Key: 40485331
• Report Number: 2031172-2016-00356
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 21062
• Device Catalogue Number: 9216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2007
• 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
• Treatment: RAINBOW DCI-DC3