MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC SINGLE LIMB CIRCUIT FOR PNEUPAC PARAPAC PLUS VENTI; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE

Catalog Number 100/905/340-CH

Patient Problem Insufficient Information (4580)

Event Date 09/18/2023

Event Type  Injury  

Event Description

Single limb ventilator circuit connected to a ventilator requiring use of a two limbed ventilator tubing circuit.Packaging lacked warning and ventilator able to deliver inspiration but did not allow for exhalation.

• Brand Name: PNEUPAC SINGLE LIMB CIRCUIT FOR PNEUPAC PARAPAC PLUS VENTI
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN 55442
• MDR Report Key: 18093658
• MDR Text Key: 327722359
• Report Number: MW5147905
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 230301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White