MAUDE Adverse Event Report: CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE CPAP; POSITIVE AIRWAY PRESSURE SYSTEM

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Emotional Changes (1831); Pain (1994); Anxiety (2328); Sensitivity of Teeth (2427); Sleep Dysfunction (2517); Suicidal Ideation (4429); Sexual Dysfunction (4510); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/20/2019

Event Type  Injury  

Event Description

Triggered mst night terrors; the (b)(6) on (b)(6) ignored my repeated reports that the cpap machine they issued me triggered military sexual trauma night terrors, physical pain, insomnia, anxiety, acid reflux, etc.They also dismissed my requested for accommodations under the americans with disabilities act on multiple occasions and dismissed my requests to provide community care appointments that were close to where i live to accommodate my traffic anxiety.They made appointments for me that were 45 minute or more drive away during little /light traffic and one appointments for a mandibular device was set for 78 miles away from my home on a route that frequently had high traffic and run work causing drive times to be high all while i was actively having traffic anxiety, back and hip pain, insomnia, night terrors, clenching of my jaw, grinding of my teeth and acid reflux from military sexual trauma triggers.The (b)(6) has severely impacted my mental and physical health and increased my thoughts of suicide.They are dismissive and neglectful.My body now goes into severe dysregulation interacting with any component of the veteran's administration.I have repeatedly contacted the (b)(6) secretary via email and called the (b)(6) hotline.I now fear seeking medical care and cannot adhere to the mask mandates because it triggers military sexual trauma physical and mental symptoms.Fda safety report id # (b)(4).

• Brand Name: CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE CPAP
• Type of Device: POSITIVE AIRWAY PRESSURE SYSTEM
• MDR Report Key: 12043287
• MDR Text Key: 257516738
• Report Number: MW5102013
• Device Sequence Number: 1
• Product Code: QBY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/20/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALEVE
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 71