MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAINBOW RC-4; OXIMETER

Model Number 2406

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/1901

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

The customer reported the readings were inaccurate.No consequences, or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned cable was evaluated.During evaluation the cable passed all visual and functional testing.During simulation testing, the cable passed manual and preset conditions and provided accurate measurements.  the cable was determined to be functioning as designed., corrected data: updated d4 lot# from blank to "20csc"; udi# from blank to (b)(4).H4: device manufacture date from blank to "04/01/2020".

Event Description

The customer reported the readings were inaccurate.No consequences or impact to patient were reported.

• Brand Name: RAINBOW RC-4
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 10897109
• MDR Text Key: 218234831
• Report Number: 3011353843-2020-00188
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2406
• Device Catalogue Number: 2406
• Device Lot Number: 20CSC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1