MAUDE Adverse Event Report: RED LNC M20-04; OXIMETER

Model Number	4252
Medical Device Problem Codes	Unable to Obtain Readings (1516); Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
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.(b)(6).
Event or Problem Description
The customer reported the device will work for a while and then stop and is sensitive to position, at times it won't read at all.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the device will work for a while and then stop and is sensitive to position, at times it won't read at all.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.The cable had a torn bend relief on the side of the m20 connector.The unit failed continuity testing due to an open in the cable at the torn bend relief area.The device failed functionality testing, a "sensor off patient" error message was displayed.

• Brand Name: RED LNC M20-04
• Common Device Name: OXIMETER
• MDR Report Key: 12063181
• Report Number: 3011353843-2021-00147
• Device Sequence Number: 4421944
• Product Code: DQA
• UDI-Device Identifier: 00843997011693
• UDI-Public: 00843997011693
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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: 4252
• Device Catalogue Number: 4252
• Device Lot Number: 20HNY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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