MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. PHASITRON 5 IPV THERAPY; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number P5

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

Patient Problems Cardiac Arrest (1762); Pneumothorax (2012)

Event Date 11/18/2021

Event Type  Injury  

Event Description

Patient with bronchiolitis in the intensive care unit was ordered ipv treatments.The phasitron 5 with caplug was used directly connected to the ett to administer nebulizing medication of albuterol and 3% normal saline via ipv.Patient experienced cardiac arrest and bilateral pneumothoraces.Fda safety report id# (b)(4).

• Brand Name: PHASITRON 5 IPV THERAPY
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; sandpoint ID 83864
• MDR Report Key: 13111171
• MDR Text Key: 282992243
• Report Number: MW5106320
• Device Sequence Number: 1
• Product Code: NHJ
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P5
• Device Catalogue Number: P5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL 3% NORMAL SALINE; IN-LINE VALVE (CAPLUG)
• Patient Outcome(s): Required Intervention
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White