MAUDE Adverse Event Report: RESMED CORP. RESMED CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37020

Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Discomfort (2330)

Event Date 08/19/2021

Event Type  Injury  

Event Description

The power connection port in my resmed cpap machine is very loose and frequently disconnects while i'm asleep, which means no air supply and suffocation with sealed mask on.Usually i notice it happening in the middle of the night because i wake up with no air flowing while my mask is on (which is a very uncomfortable and kind of scary feeling) and trying to breathe.This happens several times a week.Last night i was in a deep sleep due to some prescribed painkillers due to an injury and the power cord to the machine (not the wall outlet) became loose and i lost power the entire night and did not wake up until morning.Often when this happens, if the power is "low" but still partially connected the machine with blink its light with a warning error.I've called my doctor and equipment supplier and they said it would cost too much to order a new model.Please stop resmed.Their product is dangerous.Fda safety report id# (b)(4).

• Brand Name: RESMED CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 12359774
• MDR Text Key: 268146979
• Report Number: MW5103460
• Device Sequence Number: 1
• Product Code: BZD
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 37020
• Device Lot Number: 1144768
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 98