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

Model Number	4083
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 heart rate readings were high.No patient impact or consequences were reported.
Event or Problem Description
The customer reported heart rate readings were high.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, intermittent open in cable on the white 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.When the intermittent connection was held in normal operation and then manipulated to "open" (non-functional condition), the device went into alarm condition (audible and visually alarmed), readings zeroed out, pleth went flat, and "sensor malf" error message was displayed.The cable passed pulse rate simulation tests when the intermittent connection was held in normal operation.

• Brand Name: RD SET MP - 12
• Common Device Name: OXIMETER
• MDR Report Key: 12298070
• Report Number: 3011353843-2021-00194
• Device Sequence Number: 14555836
• Product Code: DQA
• UDI-Device Identifier: 00843997009782
• UDI-Public: 00843997009782
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/19/2021

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: 4083
• Device Catalogue Number: 4083
• Device Lot Number: 20G99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• 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