MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO CS-2; OXIMETER

Model Number 4473

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Additional manufacuring 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

Per medwatch received: "device related deep tissue injury identified to right foot during pressure injury prevalence survey on (b)(6) 2022.This injury was related to a pulse oximeter probe.The rd set neo-cs 2 probe was on the patient at the time of the survey.Wocn verified the wound and staged it.Two of the rd set neo-cs 2 probes were on the patient at the time of the survey (preductal and post-ductal monitoring).Both probes were removed and replaced with a rd set neo probe.".

• Brand Name: RD SET NEO CS-2
• 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: 15136503
• MDR Text Key: 296944022
• Report Number: 3019388613-2022-00174
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042536
• 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: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4473
• Device Catalogue Number: 4473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other