MAUDE Adverse Event Report: RD SET SL - 12; OXIMETER

Model Number	4087
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the cable either starts and then stops working or will not work at all.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.External visual inspection found no physical damage.The cable failed continuity tests, open in cable on the green conductor, along the length of the cable.Open in cable was most likely due to cable being coiled up then pulled straight based upon the appearance of the kink in the conductor jacket.The cable is malfunctioning when tested with a monitor, module, and lab sensor.The error message "sensor off patient - check connection at patient" was displayed.
Event or Problem Description
The customer reported the cable either starts and then stops working or will not work at all.No patient impact or consequences were reported.

• Brand Name: RD SET SL - 12
• Common Device Name: OXIMETER
• MDR Report Key: 12241549
• Report Number: 3011353843-2021-00177
• Device Sequence Number: 11645596
• Product Code: DQA
• UDI-Device Identifier: 00843997010559
• UDI-Public: 00843997010559
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4087
• Device Catalogue Number: 4087
• Device Lot Number: 20JDV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1