MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RADICAL-7 HANDHELD; OXIMETER

Model Number 25480

Device Problem Low Readings (2460)

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

Event Date 11/30/2021

Event Type  malfunction  

Manufacturer 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.

Event Description

The customer reported low sphb values.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.

Event Description

The customer reported low sphb values.No consequences or impact to patient were reported.

• Brand Name: RADICAL-7 HANDHELD
• 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: 13122397
• MDR Text Key: 284993333
• Report Number: 3019388613-2021-00381
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25480
• Device Catalogue Number: 9500
• 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: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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