MAUDE Adverse Event Report: PERCUSSIONAIRE PHASITRON 5; BREATHING CIRCUIT

Model Number	P5
Medical Device Problem Codes	Defective Component (2292); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received on (b)(6) 2024, from va palo alto medical center regarding a brown liquid in the phasitron 5 tubing.It was stated that they believe the circuit was used for 4 days before noticing the fluid in the tubing.No adverse reactions have been reported at this time.This report is being completed retrospectively, as it has been recently identified that there is a potential for health hazards to occur due to this issue if specific product lots are used with certain medications.
Additional Manufacturer Narrative
Percussionaire was notified about brown fluid being present in the phasitron breathing circuit on (b)(6) 2024.It was recently identified through extensive laboratory analysis that there is a risk to patient health when specific product lots are used, and therefore, this report is being submitted retrospectively.Percussionaire has learned that certain lots of the spring component within the phasitron used in the ipv system were inappropriately manufactured with a nickel coating, and that the nickel is aerosolized under normal clinical use when used with medications, such as n-acetyl cysteine or albuterol.Although we have not received any adverse events associated with this finding, there are several potential health hazards.In particular, high levels of inhaled nickel can cause lung injury related to inflammation, severe bronchospasm, reduced humoral immunity, and allergic responses.Small amounts of nickel may be measured in the mist even in normal use without medication.However, the estimated nickel exposure in this scenario is substantially below the threshold for typical in-hospital duration of therapy.An urgent medical device recall has been submitted to fda for this issue (1000524541-09/25/2024-002-r) to recall affected products.If any adverse events on this issue are reported, a follow-up mdr will be reported.

• Brand Name: PHASITRON 5
• Common Device Name: BREATHING CIRCUIT
• Manufacturer (Section D): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer (Section G): PERCUSSIONAIRE; 130 mcghee road; suite 109; sandpoint ID 83864
• Manufacturer Contact: gina cunsolo ; 130 mcghee road; suite 109; sandpoint, ID 83864
• MDR Report Key: 20408650
• Report Number: 3029845-2024-00044
• Device Sequence Number: 6261606
• Product Code: NHJ
• UDI-Device Identifier: 10849436000508
• UDI-Public: 10849436000508
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K905236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1000524541-09/25/2024-00
• Patient Sequence Number: 1
• Patient Sex: Unknown