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

Model Number 23786

Device Problem Unexpected Shutdown (4019)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: other, other text: 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.E1.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).

Event Description

The customer reported the radical-7 device "switches off automatically after about 1 minute." there was no patient impact or consequence reported.

Event Description

The customer reported the radical-7 device "switches off automatically after about 1 minute." there was no patient impact or consequence reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.The radical-7 issued a 10 beep alarm prior to shut down.The reported issue was a result of a damaged component on the instrument board.Initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).

• 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: 18136642
• MDR Text Key: 329337615
• Report Number: 3019388613-2023-00269
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997008358
• UDI-Public: 00843997008358
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23786
• 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: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• 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