MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAINBOW R1 25; OXIMETER

Model Number 3792

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported the sensor provides low readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.  during simulation testing, the sensor passed manual and preset conditions and provided accurate measurements.The sensor was determined to be functioning as designed.  initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

Event Description

The customer reported the sensor provides low readings.No patient impact or consequences were reported.

• Brand Name: RAINBOW R1 25
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11016370
• MDR Text Key: 221777417
• Report Number: 3011353843-2020-00204
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997002339
• UDI-Public: 10843997002339
• Combination Product (y/n): N
• PMA/PMN Number: K081659
• 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: 11/24/2020

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 Expiration Date: 07/15/2021
• Device Model Number: 3792
• Device Catalogue Number: 3792
• Device Lot Number: 18GGG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1