MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER

Model Number 27977

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: other, other text: the returned device was evaluated.Internal inspection revealed metallic shorting inside the on/off power button created an electrical short across the button resulting in the button being electrically pressed, even when not it was not physically pressed.This can result in the device unexpectedly powering on and off on its own.

Event Description

The customer reported the device continually shuts off.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacuring narrative: other, other text: d.10, date returned was listed as 02/12/2023, actual date is 02/13/2023.

Event Description

The customer reported the device continually shuts off.No consequences or impact to patient were reported.

• Brand Name: RAD-G PULSE OXIMETER
• 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: 16456641
• MDR Text Key: 310428924
• Report Number: 3019388613-2023-00049
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: 00843997000666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201770
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27977
• Device Catalogue Number: 9849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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
• Treatment: RD SET G15-12, PATIENT CABLE