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

Model Number 27977

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer 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 and on randomly.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: the returned device was evaluated.The device intermittently emitted a tone and powered off on its own as if the power button was pressed.Internal inspection of the device determined contamination on the circuit board power button resulted in the device powering on and off by itself.

Event Description

The customer reported the device turns off and on randomly.No patient impact or consequences 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 15859450
• MDR Text Key: 304709794
• Report Number: 3019388613-2022-00249
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997013284
• UDI-Public: 00843997013284
• 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: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27977
• Device Catalogue Number: 9847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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