MAUDE Adverse Event Report: PERCUSSIONAIRE IPV-1C; NONCONTINUOUS VENTILATOR

Model Number	F00001-C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being reported due the patient experiencing cardiac arrest.Limited information is available on this event, as the customer did not provide any additional details upon request.It was reported on june 13, 2024, by a sentec employee that a representative at (b)(6), stated that a pediatric patient experienced cardiac arrest due to application errors with an ipv-1c device.It was stated by the site representative that this event was caused by a capping issue on the phasitron breathing circuit when providing therapy directly to the patient's airway the ipv-1c current instructions for use does detail the removal of this cap when the therapy in not being given with an in-line valve.As the device was not returned for a formal investigation, and the customer adverse event forms were not returned upon request, no formal root cause has been determined at this time.No additional information is available at this time on the event or patient status.If any additional information is received, a follow up mdr will be submitted.
Event or Problem Description
On june 13, 2024, a sentec employee was made aware of an adverse event with the ipv-1c device occurring at (b)(6).Limited information is available on this event, as the customer did not provide any additional information on the event when requested.It was relayed to a sentec employee via phone call that a pediatric patient experienced cardiac arrest due to application errors with the device.It was stated the event was caused by capping the phasitron breathing circuit when administering the treatment directly to the airway.No date of when the event occurred was provided, as well as no additional information was provided on patient status.

• Brand Name: IPV-1C
• Common Device Name: NONCONTINUOUS VENTILATOR
• 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: 19729296
• Report Number: 3029845-2024-00038
• Device Sequence Number: 15501520
• Product Code: NHJ
• UDI-Device Identifier: 00849436000020
• UDI-Public: 00849436000020
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: F00001-C
• Device Catalogue Number: S00002-C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown