MAUDE Adverse Event Report: MASIMO - 40 PARKER RAINBOW R1 25L; OXIMETER

Model Number 2414

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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.

Event Description

Patient 3 of 3: the customer reported: "multiple sensor failures with r125l rainbow sensors losing sphb measurements during use.Error message reads spo2 only".Sensors work as expected initially, then 1-2 hours after surgery begins lose all rainbow measurements (sphb and spmet) giving spo2 only" message.Or environment during cardiothoracic surgery and cardiopulmonary bypass on infants around 3-10 kgs, with normal skin tones and moderate but adequate perfusion.Patients are under sterile drapes with no access to sensors during surgery." no consequences or impact to patient was reported.

• Brand Name: RAINBOW R1 25L
• 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: 6875000
• MDR Text Key: 86720879
• Report Number: 2031172-2017-00889
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997002322
• UDI-Public: 10843997002322
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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: 09/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: 2414
• Device Catalogue Number: 2414
• Device Lot Number: R17GXH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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
• Patient Weight: 5