MAUDE Adverse Event Report: SUNMED SUNMED; GUEDEL PVC SZ4

Model Number 1-1521-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 01/13/2022

Event Type  Injury  

Manufacturer Narrative

Patient involvement as the movement of bite block cause et tube giving negative pressure causing pulmonary edema.This is a reportable event.

Event Description

Does not work as a proper bite block to use during emergence and extubating from anesthesia.The patient bit onto the soft portion of this oral airway, compressing it and therefore occluding his endotracheal tube while waking up from anesthesia.This resulted in significant negative pressure pulmonary edema.The patient left the or and went to pacu intubated on a ventilator and is currently undergoing further care and assessments.

Manufacturer Narrative

Patient involvement as the movement of bite block cause et tube giving negative pressure causing pulmonary edema.This is a reportable event.The product is not intended to be used as a bite block; therefore, the account using the product in this way is a misuse by the customer.Customer has been notified and supplied with the ifu showing intended use for device.

Event Description

Does not work as a proper bite block to use during emergence and extubating from anesthesia.The patient bit onto the soft portion of this oral airway, compressing it and therefore occluding his endotracheal tube while waking up from anesthesia.This resulted in significant negative pressure pulmonary edema.The patient left the or and went to pacu intubated on a ventilator and is currently undergoing further care and assessments.

• Brand Name: SUNMED
• Type of Device: GUEDEL PVC SZ4
• Manufacturer (Section D): SUNMED; 2710 northridge dr nw; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13518552
• MDR Text Key: 285765626
• Report Number: 1314417-2022-00005
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1-1521-04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 03/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention