MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER

Model Number 4078

Device Problem Sensing Intermittently (1558)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer 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 intermittent spo2 readings.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.External visual inspection found contamination on and around the pogo pins.The device failed continuity tests due to contamination causing pogo pin #3 to stick in the barrel.As a result, the cable has an open connection on the yellow conductor.The cable was malfunctioning with no reading.The connected monitor audibly and visually alarmed.The sensor led does not illuminate.

Event Description

The customer reported intermittent spo2 readings.No patient impact or consequences were reported.

• Brand Name: RD RAINBOW SET R25-12
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11381997
• MDR Text Key: 233812520
• Report Number: 3011353843-2021-00048
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (y/n): N
• PMA/PMN Number: K042536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4078
• Device Catalogue Number: 4078
• Device Lot Number: 20G86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1