MAUDE Adverse Event Report: INTERSURGICAL INC STARMED CASTAR R HOOD; VENTILATORY ASSISTANCE HELMET

Model Number CASTAR R XL

Device Problems Use of Device Problem (1670); Pressure Problem (3012)

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

Event Date 02/01/2023

Event Description

On wednesday (b)(6) 2023, i was put in a starmed castar r hood by (b)(4), a product representative of intersurgical.I was hooked up to a philips ventilator and the device was pushing extra breaths into the hood, making me feel as if i was suffocating.The device failed.(b)(4) refused to complete and adverse incident report, due to this product only having an eua and it was going through the validation process through the fda.Both (b)(4) manager, knew this could have consequences getting the full fda approval, therefore, choosing not to report the event.I have an email from (b)(4) confirming the event happened directly from(b)(4) intersurgical representation.This can also be validated by (b)(6) assistant manger of respiratory, at the (b)(6), as he was present for this event.Also, (b)(4) was showing, promoting and marketing an accessory to the starmed castar hood, an accessory nebulizer that replaces the anti-asphyxiation valve which is not approved through the fda, not available for sale in the usa, hoping this would help sell the starmed hood to the cleveland clinic.There could be adverse reactions to this accessory if the patient is not properly trained or competent to use it.There is the ability for aerosolized medication to get into the eyes of patients if not used correctly.The medication can get in the eyes of the patients causing potential issues.

• Brand Name: STARMED CASTAR R HOOD
• Type of Device: VENTILATORY ASSISTANCE HELMET
• Manufacturer (Section D): INTERSURGICAL INC; 6757 kinne street; east syracuse NY 13057
• MDR Report Key: 16529101
• MDR Text Key: 311166751
• Report Number: MW5115645
• Device Sequence Number: 1
• Product Code: QOW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CASTAR R XL
• Device Catalogue Number: CP211XL/2RA
• Device Lot Number: 20/5288
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Patient Sequence Number: 1