MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problem Apnea (1720)

Event Date 01/05/2022

Event Type  Injury  

Event Description

Cpap machine stopped working.Has been making a loud screech for about two years which i used duct tape to fix.I had testing years ago.I don't have the results.It was severe apnea.Fda safety report id# (b)(4).

• Brand Name: SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13225042
• MDR Text Key: 283673688
• Report Number: MW5106571
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 60 YR
• Patient Sex: Female