MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RED 25 LNC-4RA SERIES; OXIMETER

Model Number	3376
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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 sensor sporadically shows no values, loses data when the cable is moved.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the sensor sporadically shows no values, loses data when the cable is moved.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.External visual inspection showed the latch at the db9 connector was missing.The sensor failed continuity testing due to an open in the cable on the green conductor.When connected to a monitor a "sensor off" error message was provided with an audible and visual alarm.Initial reporter phone # exceeded the maximum allowable characters, phone # is as follows: (b)(6).

• Brand Name: RED 25 LNC-4RA SERIES
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 11754267
• Report Number: 3011353843-2021-00102
• Device Sequence Number: 19941900
• Product Code: DQA
• UDI-Device Identifier: 00843997007085
• UDI-Public: 00843997007085
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: 3376
• Device Catalogue Number: 3376
• Device Lot Number: 20GWY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1