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

Model Number 25483

Device Problem Unexpected Shutdown (4019)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring 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 the device turns off on its own.There were no patient impact or consequences reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.The device internal battery was swollen, which prevented it from being charged.The device was not able to be powered on and would not stay powered on if not connected to an electrical power source.

Event Description

The customer reported the device turns off on its own.There were no patient impact or consequences 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 18017008
• MDR Text Key: 327265458
• Report Number: 3019388613-2023-00262
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: 00843997008358
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

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
• Device Operator: Health Professional
• Device Model Number: 25483
• 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
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2020
• 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