MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RAD-57 CONFIGURABLE PULSE CO-OXIMETER

Model Number 25195

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Per medwatch report: "when we received the monitor it was missing the reusable sensor which is necessary to have." no patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacuring narrative: the device and packaging has not been returned to allow an analysis to be performed.The customer intended to keep the product and a sensor has been provided to them.If new information is obtained or the product is returned, a follow up report will be submitted.

• Brand Name: RAD-57 CONFIGURABLE PULSE CO-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: 15696617
• MDR Text Key: 302681597
• Report Number: 3019388613-2022-00230
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997006163
• UDI-Public: 00843997006163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 25195
• Device Catalogue Number: 9216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2022
• 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