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

Catalog Number	4078
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other text: per the medwatch user facility report received from the initial reporter, the product is not available for evaluation.H3 other text : device not returned.
Event or Problem Description
The customer reported "the cable stopped responding with the monitor.It was plugged and unplugged several times.The pulse oximeter (pulse ox) on the patient was tried with another new cable and the pulse ox was then read by the monitor.This was quickly fixed and did not impact the patient for more than a few minutes.Heart rate (hr) on the monitor was reading appropriately during this time." there were no patient impact or consequences reported.

• Brand Name: RD RAINBOW SET R25-12
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 17786429
• Report Number: 3019388613-2023-00229
• Device Sequence Number: 20770983
• Product Code: DQA
• UDI-Device Identifier: 00843997010665
• UDI-Public: 00843997010665
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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 Catalogue Number: 4078
• Device Lot Number: 23CSD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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
• Patient Sex: Unknown