MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RADIUS PPG NEO; OXIMETER

Model Number 4585

Device Problem Connection Problem (2900)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturing 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 Description

The customer reported that the sensor "was losing connectivity." no consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned sensors were evaluated.All the sensors passed visual inspection and continuity testing.The sensors all failed the battery voltage test and did not meet the 3.4 vdc specification.During functionality testing, the lab monitor displayed an error message.

Event Description

The customer reported that the sensor "was losing connectivity." no consequences or impact to patient were reported.

• Brand Name: RADIUS PPG NEO
• 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12872404
• MDR Text Key: 281437799
• Report Number: 3019388613-2021-00332
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10843997014684
• UDI-Public: 10843997014684
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: 4585
• Device Catalogue Number: 4585
• Device Lot Number: 19KHD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1