MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAINBOW DCI-MINI SC 1000; OXIMETER

Model Number 3799

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing narrative: the device has not been returned to the investigation facility to allow for an analysis to be performed.  if the product is received for evaluation or new information is obtained, a follow up report will be submitted.Patient details: patient #1: weight 70kgs; patient #2: weight 53kgs; patient #3: weight 82kgs; patient #4: weight 53kgs; patient #5: weight 84kgs; patient #6: weight 81kgs; patient #7: weight 64kgs; patient #8: weight 72kgs; patient #9: weight 53kgs; patient #10: weight 51kgs; patient #11: weight 80kgs; patient #12: weight 66kgs; patient #13: weight 70kgs.Suspect medical device lot number and device manufacturer date: lot number 22gvy; device manufacture date: 8/15/2022; lot number e22c2k; device manufacture date: 4/21/2022; lot number 21dre; device manufacture date: 4/27/2021; lot number 22gcg; device manufacture date: 7/14/2022.Device not returned.

Event Description

The customer reported multiple sensors' "sphb measurements are almost always 2, 3 or even 4 points higher" than a competitor device and lab results.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the customer sent a bulk return of sensors for analysis.All the returned sensors were from the same lot as the suspected sensors.The customer advised they were not able to isolate which specific sensors were involved in the reported issue.The returned sensors were evaluated.The sensors all passed the visual inspection and continuity testing.No product performance issues related to measurement were observed.The sensors passed sphb accuracy by comparison testing.

Event Description

The customer reported multiple sensors' "sphb measurements are almost always 2, 3 or even 4 points higher" than a competitor device and lab results.No patient impact or consequences were reported.

• Brand Name: RAINBOW DCI-MINI SC 1000
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; 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: 16443518
• MDR Text Key: 310249116
• Report Number: 3019388613-2023-00041
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K182887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3799
• Device Catalogue Number: 3799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1