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

Model Number	27977
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other text: the returned device was investigated.It was confirmed there was a short inside the power button.This resulted in the on/off button being activated when not physically pressed.
Event or Problem Description
The customer reported the rad-g device powers on and off.There was no patient impact or consequence reported.
Event or Problem Description
The customer reported the rad-g device powers on and off.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the returned device was investigated and it was confirmed there was a short inside the power button.This resulted in the on/off button being activated when not physically pressed.Masimo initiated a recall for this issue and notified us fda on 2/15/2024.The recall number is z-1537-2024.D4 the catalog number was initially reported as 9849, the correct number is 9847; d4 unique identifier (udi) # was initially reported as (b)(4), the correct number is (b)(4); h7 remedial action was initially listed as other, is recall.

• Brand Name: RAD-G PULSE OXIMETER
• Common Device Name: 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: 19121672
• Report Number: 3019388613-2024-00039
• Device Sequence Number: 18204850
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: 00843997013284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 27977
• Device Catalogue Number: 9847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown