MAUDE Adverse Event Report: HILL-ROM SINGAPORE THE VEST SYSTEM; PERCUSSOR, POWERED-ELECTRIC

Model Number	P105000BT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine follow-up call by a baxter respiratory clinician with the patient, the patient reported experiencing shortness of breath three days following initiation of use of the vest device.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During a routine follow-up call by a baxter respiratory clinician with the patient, the patient reported experiencing shortness of breath three days following initiation of use of the vest device.There was no report of a device malfunction.The patient was transported to the emergency room and reported that he 'suffered a cardiac arrest.' the patient reported he was hospitalized for 25 days.The patient reports 'having procedures 'to check his veins/arteries as well as a scope of his lungs, and ct scans and x-ray.All results 'were clear with no blockages noted.' it is noted that the patient was discharged home and then re-admitted five days later for six days due to pneumonia.This patient is a 68-year-old male with a medical history of chronic obstructive pulmonary disease, broncho-mediastinal fistula, and non-small cell carcinoma s/p partial right lung resection.The vest airway clearance system was developed to provide effective airway clearance therapy.The system consists of an inflatable garment attached to an air pulse generator that rapidly inflates and deflates the inflatable garment.This causes the chest wall to be gently compressed and released, which creates airflow within the lungs.This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning.This type of airway clearance therapy is referred to as high-frequency chest wall oscillation (hfcwo).The device instructions for use states 'if conditions exist that prohibit using the vest airway clearance system, do not use the unit.Death or serious injury could occur.' the device ifu list the existence of a bronchopleural fistula as a contraindication for device use.Shortness of breath is a symptom of many underlying conditions that may or may not include injury.It is noted that this patient has a relevant medical history of copd, and a bronco mediastinal fistula (possibly related to lung resection).In this event, the patient initially experienced shortness of breath, and allegedly cardiac arrest (at a later time the same day) in which all diagnostic testing was noted to be 'clear and no blockages were noted.' the report of cardiac arrest is considered life-threatening and would require medical intervention to preclude permanent impairment of a body function or damage to a body structure, thus, a serious injury occurred.The exact cause of the reported shortness of breath and cardiac arrest is unknown, although likely related to the patient¿s underlying medical condition.The device ifu outlines contraindications of use including pleural fistula of which the patient has a known history.However, it cannot be excluded if the use of the device caused or contributed to the reported shortness of breath and subsequent alleged cardiac arrest.Of note, there was no allegation of a device malfunction, the patient has decided to discontinue use of the device.

• Brand Name: THE VEST SYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20512932
• Report Number: 3008145987-2024-00030
• Device Sequence Number: 8616717
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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
• Device Model Number: P105000BT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/23/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male