MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-G PULSE OXIMETER (WITH PATIENT CABLE)

Model Number 27977

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

The customer reported the the rad-g was powering on and off.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing 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.Initial reporter zip code exceeded maximum allowable digits, zip code is as follows: 110017.

Event Description

The customer reported the rad-g was powering on and off.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the returned device was evaluated.A shorted sw1 component on the circuit board caused the device to power on and off by itself.The shorting inside the on/off button created an electrical short which resulted in the button being activated even when the button was not physically pressed.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(6).

• Brand Name: RAD-G PULSE OXIMETER (WITH PATIENT CABLE)
• 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: 16636233
• MDR Text Key: 312314213
• Report Number: 3019388613-2023-00094
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997000666
• UDI-Public: 00843997000666
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K201770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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