MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY O3 PEDIATRIC SENSOR; OXIMETER, TISSUE SATURATION

Model Number 4235

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Per medwatch received: "patient had placement of nirs (near-infrared spectroscopy) monitors on right and left flanks and developed pressure injuries at both sites.".

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

Per medwatch received: "patient had placement of nirs (near-infrared spectroscopy) monitors on right and left flanks and developed pressure injuries at both sites.".

Manufacturer Narrative

Additional manufacturing narrative: d2 was listed as oximeter, is oximeter, tissue saturation.E4 was listed as "no", is "yes".G5 was k160526, is k182429.H1: was listed as serious injury, is malfunction.H3 other text: device not received.

• Brand Name: O3 PEDIATRIC SENSOR
• Type of Device: OXIMETER, TISSUE SATURATION
• 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: 15263122
• MDR Text Key: 298282649
• Report Number: 3019388613-2022-00184
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4235
• Device Catalogue Number: 4235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 12 KG